SIGMARecalls & reported problems across all models
Depuy (Ireland) · 380 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3,831
- Deaths reported
- 0
- Injuries reported
- 2,168
- Recalls
- 0
We found 380 models of SIGMA by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 3,831 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2017 and Sep 24, 2026 — classified as 2,168 injuries, 1,663 malfunctions.
The most frequently reported specific device problem is “Break” (659 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SIGMA problems
Device problems
- Adverse Event Without Identified Device or Use Problem1,505
- Break659
- Device-Device Incompatibility316
- Loss of or Failure to Bond273
- Naturally Worn187
- Insufficient Device Problem Information171
- Material Twisted/Bent115
- Appropriate Device Problem Term/Code Not Available84
Patient problems
- Pain858
- No Code Available713
- No Clinical Signs, Symptoms or Conditions705
- No Consequences Or Impact To Patient694
- Unspecified Infection524
- Joint Laxity264
- Insufficient Information224
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available166
SIGMA models
380 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- SIGMA 9505-01-218IMPACTOR183 reports
- SIGMA 9505-02-055IMPACTOR168 reports
- SIGMA 96-1673WRENCH102 reports
- SIGMA 2011-03-080SCREWDRIVER87 reports
- SIGMA 2024-99-111ORTHOPEDIC MANUAL SURGICAL INSTRUMENT79 reports
- SIGMA 2024-85-000CHISEL, SURGICAL, MANUAL63 reports
- SIGMA 96-0013PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER58 reports
- SIGMA 96-0005PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER53 reports
- SIGMA 1960-40-300Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing52 reports
- SIGMA 96-0083PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER52 reports
- SIGMA 96-0004PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER47 reports
- SIGMA 96-0088PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER47 reports
- SIGMA 96-0089PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER47 reports
- SIGMA 1960-50-300Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing46 reports
- SIGMA 96-0090PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER45 reports
- SIGMA 1960-50-400Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing44 reports
- SIGMA 96-0003PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER44 reports
- SIGMA 2024-40-100INSTRUMENT, CUTTING, ORTHOPEDIC43 reports
- SIGMA 2024-47-111OSTEOTOME43 reports
- SIGMA 2011-03-029ORTHOPEDIC MANUAL SURGICAL INSTRUMENT40 reports
- SIGMA 2024-40-200INSTRUMENT, CUTTING, ORTHOPEDIC40 reports
- SIGMA 96-0082PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER40 reports
- SIGMA 96-2353Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing40 reports
- SIGMA 96-0014PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER39 reports
- SIGMA 96-0015PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER36 reports
- SIGMA 96-0018PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER36 reports
- SIGMA 1960-40-500Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing35 reports
- SIGMA 1960-50-500Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing35 reports
- SIGMA 2024-11-307TEMPLATE35 reports
- SIGMA 1960-50-250Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing34 reports
- SIGMA 2011-03-013TEMPLATE34 reports
- SIGMA 1960-40-250Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing31 reports
- SIGMA 96-2355Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing31 reports
- SIGMA 1960-40-400Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing30 reports
- SIGMA 1960-01-400PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER28 reports
- SIGMA 9505-01-235TEMPLATE27 reports
- SIGMA 96-0008PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER27 reports
- SIGMA 96-0084PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER27 reports
- SIGMA 96-2354Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing27 reports
- SIGMA 1960-50-450Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing26 reports
- SIGMA 2011-03-015TEMPLATE25 reports
- SIGMA 94-0023PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER25 reports
- SIGMA 96-2344Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing25 reports
- SIGMA 86-6468PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER24 reports
- SIGMA 96-2352Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing24 reports
- SIGMA 2011-03-014TEMPLATE23 reports
- SIGMA 96-2343Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing23 reports
- SIGMA 96-2345Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing23 reports
- SIGMA 96-2361Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing23 reports
- SIGMA 96-2364Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing23 reports
- SIGMA 96-2351Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing22 reports
- SIGMA 96-2362Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing22 reports
- SIGMA 96-0086PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER20 reports
- SIGMA 96-2363Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing20 reports
- SIGMA 96-2365Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing20 reports
- SIGMA 1960-40-200Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing18 reports
- SIGMA 2024-11-407TEMPLATE18 reports
- SIGMA 96-0092PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER18 reports
- SIGMA 2024-46-010OSTEOTOME17 reports
- SIGMA 94-0013PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER17 reports
- SIGMA 9505-01-121TEMPLATE17 reports
- SIGMA 96-2342Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing17 reports
- SIGMA 1024-51-300PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER16 reports
- SIGMA 1960-40-450Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing16 reports
- SIGMA 2011-03-012TEMPLATE15 reports
- SIGMA 86-8801INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT15 reports
- SIGMA 9505-02-808TRAY, SURGICAL, INSTRUMENT15 reports
- SIGMA 96-2333Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing15 reports
- SIGMA 96-2341Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing15 reports
- SIGMA 97-0461PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER15 reports
- SIGMA 1024-52-400PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER14 reports
- SIGMA 9505-02-804TRAY, SURGICAL, INSTRUMENT14 reports
- SIGMA 96-2366Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing14 reports
- SIGMA 1960-00-400PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- SIGMA 2024-56-000DRIVER, PROSTHESIS13 reports
- SIGMA 94-0014PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- SIGMA 94-0024PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER13 reports
- SIGMA 9505-01-263TEMPLATE13 reports
- SIGMA 96-0012PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- SIGMA 96-2332Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing13 reports
- SIGMA 96-2334Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing13 reports
- SIGMA 96-2356Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing13 reports
- SIGMA 97-0462PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- SIGMA 1024-52-300PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER12 reports
- SIGMA 1024-54-307PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- SIGMA 1960-50-200Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing12 reports
- SIGMA 9505-01-238ORTHOPEDIC MANUAL SURGICAL INSTRUMENT12 reports
- SIGMA 9505-02-800TRAY, SURGICAL, INSTRUMENT12 reports
- SIGMA 96-2337Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing12 reports
- SIGMA 96-2367Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing12 reports
- SIGMA 96-6202INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT12 reports
- SIGMA 97-0451PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- SIGMA 1024-07-400PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- SIGMA 1024-53-307PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER11 reports
- SIGMA 1024-53-407PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER11 reports
- SIGMA 94-0018PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- SIGMA 94-0019PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- SIGMA 9505-02-801TRAY, SURGICAL, INSTRUMENT11 reports
- SIGMA 96-0081PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- SIGMA 96-2331Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing11 reports
Recent SIGMA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient had chronically infected knee. Surgeon did washout and poly exchange.DOI: Unknown.DOR: (b)(6) 2026.Affected side: Left knee.
Patient problems: Unspecified Infection
MAUDE report 50889254 ↗MalfunctionSep 23, 2026Difficult to Insert
It was reported that on (b)(6) 2026, the patient underwent an UKA with the product in question.During the surgery, the product in question failed to lock.Although it fit correctly during extension, a gap appeared at the front during flexion, and the surgeon repeated tried to lock but didn't work .The surgeon was forced to use the next size up¿an 8mm insert¿to complete the procedure. The surgery was completed successfully without any delay.No further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867396 ↗MalfunctionSep 22, 2026Break
It was reported that Metal part broke away from the plastic handle, 3x7mm green spacer snapped in two during removal after trialing.Couple of breakages of instruments.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852981 ↗MalfunctionSep 22, 2026Break
It was reported that Metal part broke away from the plastic handle, 3x7mm green spacer snapped in two during removal after trialing. Couple of breakages of instruments.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852980 ↗MalfunctionSep 16, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791013 ↗MalfunctionSep 15, 2026Break; Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777547 ↗MalfunctionSep 10, 2026Calibration Problem
It was reported that the torque screwdriver did not function as a torque limiter. It spun and never reached the limit. Another torque screwdriver was used. There were no negative outcomes or patient impact. The instrument was from mono instruments office set 1. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713412 ↗MalfunctionAug 18, 2026Difficult to Insert
The tibial insert poly did not click/fit in the tibia tray. The surgeon tried a few times to insert the poly, cleared the knee of possible cement and soft tissue but the poly would not sit in the tibia tray.3 different polys were opened and only the 3rd one fit in.Was there any reported patient or user harm? No.Was there a significant delay? No.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50305027 ↗MalfunctionAug 18, 2026Difficult to Insert
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50304795 ↗InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient was revised due to Knee pain. Possible infection.Activity Level - YesDOI: Unknown.DOR: Unknown .Affected Side: Left Knee.
Patient problems: Pain; Unspecified Infection
MAUDE report 50216183 ↗InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem
(b)(6) first report of retrievals for Statement of Work 10 for Q2 of 2026. (b)(6) is the research location, and not the facility of placement.A DePuy Synthes Implant was revised and reviewed for analysisReason for revision: Revision due to pain. The non-articular surface of the fixed-bearing polyethylene tibial insert shows minor yellowing.
Patient problems: Pain
MAUDE report 50180087 ↗InjuryAug 6, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Unspecified Infection
MAUDE report 50168311 ↗InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pain
MAUDE report 50168274 ↗InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pain
MAUDE report 50168263 ↗InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem
It was reported that Patient had an infected total knee. There is no implant record available so no lot codes are provided. All implants were removed. There was no loosening. No more information known.Affected Side: Left Knee.
Patient problems: Unspecified Infection
MAUDE report 50140007 ↗
Other Depuy (Ireland) products
All Depuy (Ireland) devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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