MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	0580-1-371
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the reported lot.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Exeter stem broke 1.5 years after implantation.
Additional Manufacturer Narrative
An event regarding a fracture involving an exeter stem was reported.The event was confirmed.Method & results: -device evaluation and results: not performed as product was not returned -medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: {.} cup malposition in low inclination with lack of anteversion and a medialized lower cup rim in the acetabular bone in combination with inappropriate use of an offset cup liner and use of a skirted femoral head in a morbidly obese patient have contributed to an overload condition in the arthroplasty with fatigue accumulation and ultimately a fatigue fracture of the exeter stem neck exactly at the level of peak overload.-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: the investigation concluded that {.} cup malposition in low inclination with lack of anteversion and a medialized lower cup rim in the acetabular bone in combination with inappropriate use of an offset cup liner and use of a skirted femoral head in a morbidly obese patient have contributed to an overload condition in the arthroplasty with fatigue accumulation and ultimately a fatigue fracture of the exeter stem neck exactly at the level of peak overload.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
Exeter stem broke 1.5 years after implantation.Update on 04 dec 2018 states; {.} a review of the provided medical records and x-rays by a clinical consultant indicated: {.} cup malposition in low inclination with lack of anteversion and a medialized lower cup rim in the acetabular bone in combination with inappropriate use of an offset cup liner and use of a skirted femoral head in a morbidly obese patient have contributed to an overload condition in the arthroplasty with fatigue accumulation and ultimately a fatigue fracture of the exeter stem neck exactly at the level of peak overload.

• Brand Name: EXETER V40 STEM 37.5MM NO 1
• 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: 8021980
• Report Number: 0002249697-2018-03557
• Device Sequence Number: 1434622
• Product Code: JDI
• UDI-Device Identifier: 04546540153258
• UDI-Public: 04546540153258
• Combination Product (Y/N): N
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2019

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: 10/31/2021
• Device Catalogue Number: 0580-1-371
• Device Lot Number: G6135648
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 01/10/2019
• 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: 46 YR
• Patient Weight: 140