MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	0580-1-443
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/20/2020
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.
Event or Problem Description
Revision of exeter stem.Failed due to suspected poly wear (non stryker).Update: no allegations were noted against the exeter stem.
Event or Problem Description
Revision of exeter stem.Failed due to suspected poly wear (non stryker).Update: no allegations were noted against the exeter stem.
Additional Manufacturer Narrative
Reported event: an event regarding revision involving exeter stem was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event and is therefore considered concomitant.Revision of exeter stem due to suspected poly wear was reported, the stem is not in contact with poly.The visual inspection of the returned device indicated: damages was observed on the examined device consistent with explantation damage.There is no allegation against the exeter stem.The reported poly is a non stryker device, therefore no investigation for poly is required.

• Brand Name: EXETER V40 STEM 44MM 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: 10142880
• Report Number: 0002249697-2020-01152
• Device Sequence Number: 3184152
• Product Code: JDI
• UDI-Device Identifier: 04546540153326
• UDI-Public: 04546540153326
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020

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 Model Number: 0580-1-443
• Device Catalogue Number: 0580-1-443
• Device Lot Number: GA687950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 08/25/2020
• 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: 70 YR
• Patient Weight: 66