DJO SURGICAL 508-00-000Recalls & reported problems
Encore Medical, L.P. · SOCKET, SHELL NEUTRAL RSP · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00888912024600), received between Sep 29, 2015 and Sep 16, 2025 — classified as 21 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).
4 other recalls cover devices cleared under the same FDA submission (K041066); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem7
- Appropriate Device Problem Term/Code Not Available3
- Device Dislodged or Dislocated3
- Insufficient Device Problem Information2
- Unstable2
- Contamination1
- Device Slipped1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Code Available8
- Unspecified Infection4
- Failure of Implant2
- Joint Dislocation2
- Edema1
- Implant Pain1
- Joint Laxity1
- Loss of Range of Motion1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND INFECTION.
Patient problems: Implant Pain; Unspecified Infection
MAUDE report 17822425 ↗InjuryJan 15, 2019Microbial Contamination of Device
REVISION SURGERY - DUE TO THE PATIENT DEVELOPING SYMPTOMS OF AN INFECTION. AN IRRIGATION AND DEBRIDEMENT WAS PREFORMED WHERE THE SHELL, LINER AND GLENOID HEAD WERE REPLACED.
Patient problems: No Code Available
MAUDE report 8250582 ↗InjuryAug 22, 2018Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT BEING UNSTABLE.
Patient problems: No Code Available
MAUDE report 7806789 ↗InjuryApr 4, 2018Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT HAVING A RIGHT SIDE DEEP INFECTION.
Patient problems: Unspecified Infection
MAUDE report 7397373 ↗InjuryApr 4, 2018Device Dislodged or Dislocated
REPORTED INCIDENT - DUE TO THE PATIENT HAVING A RIGHT SHOULDER DISLOCATION.
Patient problems: Failure of Implant
MAUDE report 7397371 ↗InjuryApr 4, 2018Adverse Event Without Identified Device or Use Problem
REPORTED INCIDENT - DUE TO THE PATIENT HAVING RIGHT SHOULDER SWELLING; EDEMA.
Patient problems: Edema; Swelling
MAUDE report 7397367 ↗InjuryJan 3, 2018Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT BEING A LITTLE LOOSE.
Patient problems: Failure of Implant
MAUDE report 7160478 ↗InjuryDec 15, 2017Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT COMPLAINING OF PAIN WHEN MOVING SHOULDER. THE SURGEON TOOK X-RAYS AND THERE APPEARED TO BE AN OSTEOPHYTE INFERIOR TO THE GLENOID. SURGEON SUSPECTED IT CAUSED THE PROSTHESIS TO IMPINGE. DURING SURGERY, IT WAS DISCOVERED THAT THE PROSTHESIS WAS ABLE TO BE DISLOCATED TOO EASILY. THERE WAS NOT ENOUGH TENSION SO THE SURGEON HAD TO BUILD UP THICKNESS; DISCOVERED NOT IMPINGING.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 7120750 ↗InjuryAug 18, 2017Inadequacy of Device Shape and/or Size; Device Slipped
REVISION SURGERY - DUE TO THE SURGEON WANTING A THICKER POLY; SURGEON SAID THERE WAS LOOSENING.
Patient problems: No Code Available
MAUDE report 6804826 ↗InjuryJun 1, 2017Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE SURGEON THOUGHT THE SOCKET HAD DISENGAGED BUT WAS STILL INTACT WHEN THE PATIENT WAS OPENED.
Patient problems: No Information
MAUDE report 6606719 ↗InjuryMar 31, 2017Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE MODULAR SHELL DISASSOCIATING FROM THE STEM. THE PROBLEM WAS THAT THE ORIGINAL SURGEON DID NOT IMPACT THE SHELL HARD ENOUGH TO THE STEM TO LOCK IT IN. WE REPLACED THE SHELL, LINER, AND GLENOSPHERE AND THE OUTCOME WAS SUCCESSFUL.
Patient problems: No Code Available
MAUDE report 6451419 ↗InjuryMar 31, 2017Use of Device Problem; Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE MODULAR SHELL HAVING DISASSOCIATED FROM THE STEM. THE PROBLEM WAS THAT THE ORIGINAL SURGEON DID NOT IMPACT THE SHELL HARD ENOUGH TO THE STEM TO LOCK IT IN. THE SURGEON REPLACED THE SHELL, LINER, AND GLENOSPHERE AND THE OUTCOME WAS SUCCESSFUL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6450651 ↗InjuryJan 7, 2017Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE HUMERAL STEM BEING LOOSE; THE SURGEON REMOVED THE ORIGINAL STEM, SHELL AND LINER. HE REPLACED THEM WITH AN ADDED SPACER, STEM AND LINER.
Patient problems: No Code Available
MAUDE report 6231855 ↗InjuryDec 22, 2016Unstable
REVISION SURGERY - THE PATIENT'S ORIGINAL SURGERY ((B)(4)) TOOK PLACE ON (B)(6) 2014. ANOTHER ((B)(4)) TOOK PLACE ON (B)(6) 2014. ANOTHER REVISION ((B)(4)) TOOK PLACE ON (B)(6) 2015. THE LAST SURGERY TOOK PLACE ON (B)(6) 2016. ALL REVISIONS TOOK PLACE BECAUSE THE PATIENT WAS UNSTABLE AND THE SURGEON KEPT INCREASING THE GLENOID SIZE IN ORDER TO TRY TO MAKE THE JOINT STABLE. HE WAS UNSUCCESSFUL, THUS REMOVING ALL DJO IMPLANTS, ACCORDING TO THE REPRESENTATIVE.
Patient problems: No Code Available
MAUDE report 6201581 ↗InjuryMar 3, 2016Insufficient Device Problem Information
InjuryFeb 15, 2016Contamination
REVISION SURGERY - DUE TO THE PATIENT BEING BADLY INFECTED. THE SURGEON TOOK EVERYTHING OUT AND BUILT AN ANTIBIOTIC SPACER OUT OF TURON STEM.
Patient problems: Unspecified Infection
MAUDE report 5436328 ↗InjuryOct 6, 2015Insufficient Device Problem Information
REVISION SURGERY - DUE TO AN INFECTION IN THE PATIENT'S SHOULDER, NOT DUE TO THE IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 5129742 ↗InjurySep 29, 2015Unstable
REVISION SURGERY - DUE TO THE PATIENT'S SHOULDER HAVING INSTABILTY.
Patient problems: No Code Available
MAUDE report 5112398 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K041066. One submission often covers many models, so check the product and lot details in each record.
- Z-0098-2024 · Aug 22, 2023 · Open, ClassifiedREVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
- Z-0185-2008 · Aug 8, 2007 · TerminatedEncore Reverse Shoulder Prosthesis (RSP) System, Standard Size 40 RSP Humeral Socket Insert; Catalog #: 508-00-040; Sterile; Manufactured by Encore, Medical, L.P., Austin, TX 7875
- Z-0184-2008 · Aug 8, 2007 · TerminatedEncore Reverse Shoulder Prosthesis (RSP) System, Standard Size 36 RSP Humeral Socket Insert; Catalog #: 508-00-036; Sterile; Manufactured by Encore, Medical, L.P., Austin, TX 7875
- Z-1566-05 · Jul 28, 2005 · TerminatedEncore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, L.P. 9800 Metric Blvd., Austin, Texas 78758
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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