MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	502-03-50D
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The cup is gradually loosening and moving.The patient had a little pain at the beginning of the movement, but the pain disappeared as she walked.Revision due to cup loosening.Primary surgery on 2012.
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Additional Manufacturer Narrative
An event regarding loosening involving a trident shell was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device has dents and scratches on the exterior and interior surfaces of the shell.Damage is consistent with attempted explantation.There is no evidence of osseointegration in the form of bone residue anywhere on the device.-clinician review: a review of the provided medical information by a clinical consultant indicated: "this inquiry reports the failure of an acetabular cup at about 10 years after implantation due to loosening.I can confirm that this event took place since i was able to see serial xrays.The xrays provided shows that fixation was most likely suboptimal with an immediate post operative radiolucency around the cup.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of acetabular loosening is multifactorial including surgical technique factors with inadequate initial fixation.In my opinion this cup never achieved adequate initial fixation and went on to symptomatic loosening.In my opinion the surgeon should be counseled regarding the importance of initial stable fixation to insure longevity.Again, in my opinion there is ¿nothing wrong¿ with the cup." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to cup loosening.The device was returned for evaluation.Visual inspection of the returned device indicated that the device has dents and scratches on the exterior and interior surfaces of the shell.Damage is consistent with attempted explantation.There is no evidence of osseointegration in the form of bone residue anywhere on the device.A review of the provided x-rays by a clinical consultant indicated the following: "this inquiry reports the failure of an acetabular cup at about 10 years after implantation due to loosening.I can confirm that this event took place since i was able to see serial xrays.The xrays provided shows that fixation was most likely suboptimal with an immediate post operative radiolucency around the cup.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of acetabular loosening is multifactorial including surgical technique factors with inadequate initial fixation.In my opinion this cup never achieved adequate initial fixation and went on to symptomatic loosening.In my opinion the surgeon should be counseled regarding the importance of initial stable fixation to insure longevity.Again, in my opinion there is ¿nothing wrong¿ with the cup." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The cup is gradually loosening and moving.The patient had a little pain at the beginning of the movement, but the pain disappeared as she walked.Revision due to cup loosening.Primary surgery on 2012.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13248750
• Report Number: 0002249697-2022-00077
• Device Sequence Number: 4582918
• Product Code: LPH
• UDI-Device Identifier: 07613327040135
• UDI-Public: 07613327040135
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: 502-03-50D
• Device Catalogue Number: 502-03-50D
• Device Lot Number: 40649201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female