MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 50MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	0580-1-501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
Revision case.
Additional Manufacturer Narrative
An event regarding revision involving an exeter stem was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection: visual inspection of the device indicated that the device was returned in used condition.Scratches were observed on the device.This damage is consistent with time spent implanted in the body in contact with cement, followed by attempted explantation.No further surface discrepancies were observed.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: no medical records were received for review with a clinical consultant.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: no other similar events were reported for the lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, and x-rays 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
Revision case.

• Brand Name: EXETER V40 STEM 50MM NO 1
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12726719
• Report Number: 0002249697-2021-01805
• Device Sequence Number: 19944960
• Product Code: LPH
• UDI-Device Identifier: 04546540153364
• UDI-Public: 04546540153364
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022

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: 01/31/2015
• Device Model Number: 0580-1-501
• Device Catalogue Number: 0580-1-501
• Device Lot Number: G2951764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown