MobileLink Acetabular Cup SystemRecalls & reported problems across all models
WALDEMAR LINK GmbH & Co. KG · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one MobileLink Acetabular Cup System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 1
We found 8 models of MobileLink Acetabular Cup System by WALDEMAR LINK GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 10 adverse event reports in the FDA's MAUDE database, received between Feb 7, 2022 and Mar 9, 2026 — classified as 4 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (4 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
MobileLink Acetabular Cup System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 14, 2023Open, Classified
Product is labeled with incorrect offset.
Z-2641-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported MobileLink Acetabular Cup System problems
Device problems
- Positioning Failure4
- Detachment of Device or Device Component2
- Osseointegration Problem2
- Positioning Problem2
- Separation Failure1
- Unclear Information1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information3
- Pain2
- Bone Fracture(s)1
- Failure of Implant1
- Inadequate Osseointegration1
- Joint Laxity1
MobileLink Acetabular Cup System models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MobileLink Acetabular Cup System 183-610/05PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall1 report
- MobileLink Acetabular Cup System 183-101/52PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- MobileLink Acetabular Cup System 183-371/32PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- MobileLink Acetabular Cup System 183-101/44Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate1 report
- MobileLink Acetabular Cup System 183-101/46PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- MobileLink Acetabular Cup System 183-101/50Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate1 report
- MobileLink Acetabular Cup System 183-362/36Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- MobileLink Acetabular Cup System 183-364/36Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
Recent MobileLink Acetabular Cup System adverse event reports
The 10 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 9, 2026Unintended Movement
"NOTIFIED THAT A MOBILELINK CUP IMPLANTED ON (B)(6) 2025 BY DR. (B)(6). IS GETTING REVISED BECAUSE THE CUP "SPUN OUT" BUT THE SCREWS ARE STILL CONNECTED. REVISION WILL BE DONE ON THE EVENING OF (B)(6) 2026." "[CUSTOMER]".
Patient problems: Insufficient Information
MAUDE report 24542621 ↗InjuryMar 4, 2026Detachment of Device or Device Component
NOTIFIED THAT A MOBILELINK CUP IMPLANTED ON (B)(6) 2025 BY DR. (B)(6) IS GETTING REVISED BECAUSE THE CUP "SPUN OUT" BUT THE SCREWS ARE STILL CONNECTED. REVISION WILL BE DONE ON THE EVENING OF (B)(6) 2026. UNKNOWN EVENT OR EVENT DATE.
Patient problems: Joint Laxity
MAUDE report 24507763 ↗MalfunctionNov 12, 2025Positioning Failure; Positioning Problem; Positioning Failure; Positioning Problem
POSITIONING PROBLEM OF THE LINER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23531045 ↗MalfunctionOct 17, 2025Positioning Failure; Positioning Failure
"NOTIFIED BY (B)(6) ON (B)(6) 2025, THAT 2 MOBILELINK INSERTS WOULD NOT SEAT ONTO THE SHELL DURING A PROCEDURE. THERE WAS APPROXIMATELY A 20 MINUTE DELAY IN THE PROCEDURE. THE 48 MM SHELL (183-101/48) WAS IMPLANTED WITH 2 SCREWS IN PLACE, BUT THE LINER WOULD NOT SEAT CORRECTLY. THERE WAS NO EVIDENCE OF THE SCREWS BEING PROUD. THE SCREWS WERE REMOVED AND THE LINER STILL DID NOT SEAT. AN ADDITIONAL LINER WAS OPENED BUT IT ALSO DID NOT SEAT CORRECTLY. THEN THE SHELL WAS INSTEAD CHANGED TO A TRABECULINK SHELL (183-201/48) BUT NEITHER OF THE 2 LINERS STILL DID NOT SEAT. A 183-361/32 LINER WAS FINALLY USED AND IT SEATED CORRECTLY. THE PARTS IMPLANTED WERE 183-201/48, LOT 220302/0848 WITH 183-361/32, LOT 2323127. THE SHELL AND BOTH INSERTS ARE BEING SHIPPED FOR THE INVESTIGATION." [CUSTOMER]
Patient problems: Insufficient Information
MAUDE report 23320612 ↗MalfunctionOct 17, 2025Positioning Failure; Positioning Failure
"NOTIFIED BY (B)(6) ON (B)(6) 2025, THAT 2 MOBILELINK INSERTS WOULD NOT SEAT ONTO THE SHELL DURING A PROCEDURE. THERE WAS APPROXIMATELY A 20 MINUTE DELAY IN THE PROCEDURE. THE 48 MM SHELL (183-101/48) WAS IMPLANTED WITH 2 SCREWS IN PLACE, BUT THE LINER WOULD NOT SEAT CORRECTLY. THERE WAS NO EVIDENCE OF THE SCREWS BEING PROUD. THE SCREWS WERE REMOVED AND THE LINER STILL DID NOT SEAT. AN ADDITIONAL LINER WAS OPENED BUT IT ALSO DID NOT SEAT CORRECTLY. THEN THE SHELL WAS INSTEAD CHANGED TO A TRABECULINK SHELL (183-201/48) BUT NEITHER OF THE 2 LINERS STILL DID NOT SEAT. A 183-361/32 LINER WAS FINALLY USED AND IT SEATED CORRECTLY. THE PARTS IMPLANTED WERE 183-201/48, LOT 220302/0848 WITH 183-361/32, LOT 2323127. THE SHELL AND BOTH INSERTS ARE BEING SHIPPED FOR THE INVESTIGATION." [CUSTOMER].
Patient problems: Insufficient Information
MAUDE report 23320611 ↗MalfunctionFeb 20, 2025Positioning Failure; Positioning Problem; Positioning Failure; Positioning Problem
POLY INSERT DID NOT ENGAGE. [CUSTOMER].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21421792 ↗MalfunctionAug 15, 2024Separation Failure; Separation Failure
DURING TOTAL HIP REPLACEMENT SURGERY, ONE SCREW OF THE 46MM MOBILELINK ACETABULAR CUP COULD NOT BE REMOVED, RESULTING IN A MODIFIED SURGICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19989992 ↗MalfunctionJul 17, 2023Unclear Information; Unclear Information
PLEASE SEE ATTACHED COMPLAINT RE LABELLING ISSUE WITH MOBILELINK LINER 183-610/05, ALSO BELOW IMAGE SHOWS THE LABEL STATES +8MM RATHER THAN +12MM AS SHOULD BE. THE REPRESENTATIVE NOTICED THE DISCREPANCY IN THE LABELING WHEN CHECKING CUSTOMER'S INVENTORY. [CUSTOMER].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17335124 ↗InjuryMay 31, 2023Osseointegration Problem; Osseointegration Problem
InjuryFeb 7, 2022Detachment of Device or Device Component; Osseointegration Problem; Detachment of Device or Device Component; Osseointegration Problem
3 MONTHS AFTER A PATIENT UNDERWENT A SURGICAL PROCEDURE, THE ACETABULAR CUP GOT LOOSE ALONG WITH THE SCREW.
Patient problems: Failure of Implant; Inadequate Osseointegration; Pain
MAUDE report 13469090 ↗
Other WALDEMAR LINK GmbH & Co. KG products
- Unicondylar Sled Prosthesis48 models · 12 reports · 48 recalls
- Endo-Model Modular Knee Prosthesis System64 models · 57 reports · 12 recalls
- LinkSymphoKnee117 models · 79 reports · 11 recalls
- LINK Instrument14 models · 8 reports · 12 recalls
- Endo-Model SL Knee Prosthesis System25 models · 52 reports · 6 recalls
- Endo-Model Standard Knee Prosthesis System15 models · 19 reports · 6 recalls
- LINK Embrace Shoulder System Line Extension2 models · 1 reports · 4 recalls
- SPII Model Lubinus174 models · 6 reports · 3 recalls
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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