MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	0580-1-441
Medical Device Problem Codes	Corroded (1131); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	07/06/2021
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 following devices were also listed in this report: mitch head - 48-4004 v40 0448; cat# unk_shc; lot# fm069282.Std mitch trh cp sz 48/54; cat# mac-9988-4854; lot# fm61631005.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
The customer reported that the patient who had previously been implanted with an exeter mitch combination has been revised.Update: revision left hip patient had very high metal ion levels.
Additional Manufacturer Narrative
Reported event: an event regarding corrosion and abnormal ion level involving an exeter stem was reported.The corrosion event was confirmed via evaluation of the returned device.Abnormal ion level was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the trunnion of the stem has a reddish-brown discoloration.Material analysis: a material analysis was performed and concluded the following: "the abrasive wear seen on the medial surface is consistent with micromotion of the stems polished surface while implanted in the femur with surgical cement.The reddish brown discoloration seen on and near the trunnion is consistent with being a corrosion product.No fractures were seen on the returned stem.No material non-conformances, nor any manufacturing defects were seen on any of the surfaces inspected here." -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.Visual inspection of the returned device indicated that the trunnion of the stem has a reddish-brown discoloration.A material analysis was performed and concluded the following: "the abrasive wear seen on the medial surface is consistent with micromotion of the stems polished surface while implanted in the femur with surgical cement.The reddish brown discoloration seen on and near the trunnion is consistent with being a corrosion product.No fractures were seen on the returned stem.No material non-conformances, nor any manufacturing defects were seen on any of the surfaces inspected here." further information in the form of pathology reports, revision operation report, and patient history notes are needed to confirm high metal ions in the patient.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.
Event or Problem Description
The customer reported that the patient who had previously been implanted with an exeter mitch combination has been revised.**update** revision left hip patient had very high metal ion levels.

• Brand Name: EXETER V40 STEM 44MM NO 1
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12252692
• Report Number: 0002249697-2021-01299
• Device Sequence Number: 17393854
• Product Code: JDI
• UDI-Device Identifier: 04546540153302
• UDI-Public: 04546540153302
• 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 Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2022

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: 11/30/2012
• Device Model Number: 0580-1-441
• Device Catalogue Number: 0580-1-441
• Device Lot Number: G2113600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 10/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2007
• 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 Sex: Unknown