MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CONSTRAINED ACETABULAR INSERTS; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	2099-2250
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device evaluated by manufacturer? device not available.
Event or Problem Description
It was reported that the patient's right hip was revised due to disassociation of the constrained liner out of the acetabular shell.Intra-operatively, the metal ring of the constrained liner was reported as broken ("snapped"), and the inner edge of the shell was reported as being asymmetric due to wear.A 54mm series ii acetabular shell, 50mm howmedica osteonics constrained acetabular insert, and stryker femoral head were revised to a trident ii shell with 6 screws, a trident constrained liner, and another stryker femoral head.Rep confirmed there were no allegations against the femoral head.The explants are available for return.Otherwise, rep confirmed that no further information is available.
Additional Manufacturer Narrative
An event regarding disassociation involving constrained acetabular insert was reported.The event was confirmed.Method & results: device evaluation and results: there appears to be damage on the surface from contact with mating parts of the insert.The locking ring has been deformed.Damage was observed on the shell and liner consistent with contact against the locking wire.The locking wire was likely deformed out of the channel on the liner and was impinged against the liner and shell causing the damage observed on both surfaces.Damage to the locking ring has been known to compromise the seating of the acetabular insert into the shell.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all 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 reported lot.Conclusion: no further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right hip was revised due to disassociation of the constrained liner out of the acetabular shell.Intra-operatively, the metal ring of the constrained liner was reported as broken ("snapped"), and the inner edge of the shell was reported as being assymetric due to wear.A 54mm series ii acetabular shell, 50mm howmedica osteonics constrained acetabular insert, and stryker femoral head were revised to a trident ii shell with 6 screws, a trident constrained liner, and another stryker femoral head.Rep confirmed there were no allegations against the femoral head.The explants are available for return.Otherwise, rep confirmed that no further information is available.

• Brand Name: CONSTRAINED ACETABULAR INSERTS
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8897456
• Report Number: 0002249697-2019-02867
• Device Sequence Number: 259968
• Product Code: KWZ
• UDI-Device Identifier: 07613327031430
• UDI-Public: 07613327031430
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P960047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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: 06/30/2020
• Device Catalogue Number: 2099-2250
• Device Lot Number: 4887J9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR