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

Model Number	69-2850
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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
It has been reported that there was a trident cemented constrained liner implanted during a revision surgery.After the reduction of the hip, the inner part of the constrained liner + the femoral head disassociated from the external part of the liner, which stayed in the patient (since it was cemented in the socket).It was impossible to perform the reduction again, so the surgeon proceed to extract the liner, which came out together with the cement mantle and the anterior wall of the acetabulum of the patient.
Additional Manufacturer Narrative
An event regarding disassociation involving all poly constrained insert 50mm was reported.The event was confirmed based on inspection.Method & results: -device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The bipolar head appears to be disassociated from the poly liner.Dimensional inspection: not performed as the dimensional aspects are not in question functional inspection: not performed as the functional aspects are not in question.Material analysis not performed as this event does not relate to material integrity.-clinician review: a review of the provided medical records rejected by a clinical consultant stated the following comment: no clinical or pmh, no patient demographics, no operative reports, no serial imaging studies, and no examination of explanted components.Based upon the single x-ray available for review, no confirmation of the event description or creating of a medical report is possible.-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: it was reported that there was a trident cemented constrained liner implanted during a revision surgery.After the reduction of the hip, the inner part of the constrained liner + the femoral head disassociated from the external part of the liner, which stayed in the patient.The reported device was not returned however photographs were provided for review.The bipolar head appears to be disassociated from the poly liner.A review of the provided medical records rejected by a clinical consultant stated the following comment: no clinical or pmh, no patient demographics, no operative reports, no serial imaging studies, and no examination of explanted components.Based upon the single x-ray available for review, no confirmation of the event description or creating of a medical report is possible.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It has been reported that there was a trident cemented constrained liner implanted during a revision surgery.After the reduction of the hip, the inner part of the constrained liner + the femoral head disassociated from the external part of the liner, which stayed in the patient (since it was cemented in the socket).It was impossible to perform the reduction again, so the surgeon proceed to extract the liner, which came out together with the cement mantle and the anterior wall of the acetabulum of the patient.

• 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: 9708838
• Report Number: 0002249697-2020-00290
• Device Sequence Number: 19752430
• Product Code: KWZ
• UDI-Device Identifier: 07613327025477
• UDI-Public: 07613327025477
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

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: 11/30/2023
• Device Model Number: 69-2850
• Device Catalogue Number: 69-2850
• Device Lot Number: RA6R21
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 05/05/2020
• 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: 87 YR