MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	0580-1-373
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	05/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.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 not available.
Event or Problem Description
The patient underwent a revision of a hemiarthroplasty, on the right hip, following progression of his disease.He presented with groin pain believed to be due to acetabular wear.There was also some subsidence of the femoral stem.The stem and bi polar head were removed, and the acetabulum was revised and a short stem cemented into the remaining cement mantle.
Additional Manufacturer Narrative
An event regarding subsidence involving an exeter stem was reported.The event was confirmed through clinician review of the provided x-rays.Method & results: -product evaluation and results: not performed as no product was returned for evaluation.-clinician review: a review of the provided medical records by a clinical consultant indicated: x-rays available for review include two undated ap x-rays of the right hip demonstrating a cemented bipolar hip arthroplasty, reduced, with evidence of the stem and cement mantle having subsided approximately 1-centimeter.No acetabular joint space is noted in charnley zones ii and iii, suggesting arthritis of the host acetabulum.The event description states, ¿¿ revision of a hemiarthroplasty ¿ following progression of his disease ¿ groin pain believe to be due to acetabular wear ¿ also some subsidence of the femoral stem ¿¿.There is no examination of the explanted components and no revision operative report available.The pre-revision x-rays confirm the event description of progressive arthritis of the host acetabulum and some femoral component subsidence.Revision to a hybrid total hip arthroplasty was indicated for this condition, which was not related to factors associated with manufacturing or material of the primary bipolar hip arthroplasty components.-product history review: indicated 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 referenced.Conclusion: a review of the provided medical records by a clinical consultant indicated: x-rays available for review include two undated ap x-rays of the right hip demonstrating a cemented bipolar hip arthroplasty, reduced, with evidence of the stem and cement mantle having subsided approximately 1-centimeter.No acetabular joint space is noted in charnley zones ii and iii, suggesting arthritis of the host acetabulum.The event description states, ¿¿ revision of a hemiarthroplasty ¿ following progression of his disease ¿ groin pain believe to be due to acetabular wear ¿ also some subsidence of the femoral stem ¿¿.There is no examination of the explanted components and no revision operative report available.The pre-revision x-rays confirm the event description of progressive arthritis of the host acetabulum and some femoral component subsidence.Revision to a hybrid total hip arthroplasty was indicated for this condition, which was not related to factors associated with manufacturing or material of the primary bipolar hip arthroplasty components.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The patient underwent a revision of a hemiarthroplasty, on the right hip, following progression of his disease.He presented with groin pain believed to be due to acetabular wear.There was also some subsidence of the femoral stem.The stem and bi polar head were removed, and the acetabulum was revised and a short stem cemented into the remaining cement mantle.

• Brand Name: EXETER V40 STEM 37.5MM NO 3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8691180
• Report Number: 0002249697-2019-02233
• Device Sequence Number: 16625476
• Product Code: JDI
• UDI-Device Identifier: 04546540153272
• UDI-Public: 04546540153272
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 08/06/2019

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 Catalogue Number: 0580-1-373
• Device Lot Number: G3250675
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 08/06/2019
• 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: 80 YR
• Patient Weight: 101