MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALL POLY CONSTRAINED INSERT 50MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	69-2850
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	07/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
Dislocation left prosthetic hip replacement.Constrained cemented liner in situ.Revision hip surgery july 4th.Apparent dislocation and dissociation of stryker cemented constrained liner (large articulating head with outer casing).Liner was revised with a new device of the same category number.The femoral stem was revised for acetabular access.Primary hip surgery approximately 4 weeks ago.Custom hemipelvic tumour prosthesis with stryker all poly constrained liner 50mm, exeter 44 no 0 hip stem and 28 + 0 head.The exact item and lot codes are not yet available.
Event or Problem Description
Dislocation left prosthetic hip replacement.Constrained cemented liner in situ.Revision hip surgery (b)(6).Apparent dislocation and dissociation of stryker cemented constrained liner (large articulating head with outer casing).Liner was revised with a new device of the same category number.The femoral stem was revised for acetabular access.Primary hip surgery approximately 4 weeks ago.Custom hemipelvic tumour prosthesis with stryker all poly constrained liner 50mm, exeter 44 no 0 hip stem and 28 + 0 head.The exact item and lot codes are not yet available.
Additional Manufacturer Narrative
Correction: lot code updated an event regarding a dislocation involving an all poly constrained liner was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 31-october-2019.This inspection indicated: nothing noteworthy was observed on the surfaces of the locking wire of the insert.Damage was observed on the uhmwpe acetabular insert consistent with the explantation process.A material analysis has been performed.The report concluded: damage consistent with the implantation/explantation process was observed on the stem (neck and main body), articulating surface of the bipolar outer femoral head, distal rim of the femoral head, and acetabular insert.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: a review of the provided medical records by a clinical consultant stated the following comment: one undated x-ray and intraop photos confirms disassociation of constrained liner, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports and progress notes are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.

• Brand Name: ALL POLY CONSTRAINED INSERT 50MM
• 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: 8841778
• Report Number: 0002249697-2019-02725
• Device Sequence Number: 318368
• Product Code: KWZ
• UDI-Device Identifier: 07613327025477
• UDI-Public: 07613327025477
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K061654
• 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): 12/04/2019

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: 12/31/2023
• Device Catalogue Number: 69-2850
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 12/04/2019
• 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