MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	0580-1-442
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Insufficient Information (4580)
Date of Event	02/01/2022
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 the mitch trh acetabular system components are oem devices.Stryker orthopaedics is not the legal manufacturer of the mitch devices and does not have reporting responsibilities.However, since this device was used in conjunction with a stryker device they are being listed as associated devices.Std mitch trh cp sz 52/58; cat # mac-9988-5258; lot # fm059456.Mitch trh md hd sz52-4; cat # mmh-9988-0452; lot # fm073567.
Event or Problem Description
The following was reported: the patient had an exeter/mitch thr revision.
Event or Problem Description
The following was reported: the patient had an exeter/mitch thr revision.Update 16-mar-2022: "reason for revision was the same as always with these exeter mitch combinations (high metal ion levels, metallosis and severely damaged exeter stem trunnions.During the revision the metallosis and significantly damaged trunnion were confirmed.".
Additional Manufacturer Narrative
Reported event: an event regarding wear and abnormal ion level involving an exeter stem was reported.The wear event was confirmed via evaluation of the returned device.The abnormal ion level event was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device noticed a notch on the stem neck and trunnion wear which are likely caused due to contact against hard object.Explantation damage was also observed on the device.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the patient was revised due to high metal ions, metallosis, and wear of the trunnion of the exeter stem.Visual inspection of the returned device noticed a notch on the stem neck and trunnion wear which are likely caused due to contact against hard object.Explantation damage was also observed on the device.The wear event was confirmed but insufficient information was provided to confirm elevated metal ions.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: EXETER V40 STEM 44MM NO 2
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 13602776
• Report Number: 0002249697-2022-00280
• Device Sequence Number: 5833536
• Product Code: LPH
• UDI-Device Identifier: 04546540153319
• UDI-Public: 04546540153319
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022

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: 07/31/2012
• Device Model Number: 0580-1-442
• Device Catalogue Number: 0580-1-442
• Device Lot Number: G1909598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2007
• 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 Age: 57 YR
• Patient Sex: Male