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

Model Number	0580-1-442
Medical Device Problem Codes	Corroded (1131); Material Erosion (1214)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530)
Date of Event	08/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device noted as returned.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Catalog numbers and lot codes of other devices listed in this report: device name#std mitch trh cp sz 52/58 ; cat#mac-9988-5258 ; lot#fm-63060-004, device name#mitch trh md hd sz52+0 ; cat#mmh-9988-0052 ; lot#fm60276.
Event or Problem Description
Patient was revised due to high metal ion levels.Exeter/mitch combination revised.
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 is damaged.This damage was consistent with the interaction between the head taper and stem trunnion.Black debris was also observed on the stem trunnion.The appearance of the debris is consistent with a corrosion product and material transfer from the head/biological material.Plastic surface deformation consistent with micro-motion at the stem-cement interface was also observed on the body of the stem in addition to damage consistent with contact with explantation tooling.-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 is damaged.This damage was consistent with the interaction between the head taper and stem trunnion.Black debris was also observed on the stem trunnion.The appearance of the debris is consistent with a corrosion product and material transfer from the head/biological material.Plastic surface deformation consistent with micro-motion at the stem-cement interface was also observed on the body of the stem in addition to damage consistent with contact with explantation tooling.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the revision 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.
Event or Problem Description
Patient was revised due to high metal ion levels.Exeter/mitch combination revised.

• Brand Name: EXETER V40 STEM 44MM NO 2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 15377935
• Report Number: 0002249697-2022-01310
• Device Sequence Number: 12165841
• Product Code: LPH
• UDI-Device Identifier: 04546540153319
• UDI-Public: 04546540153319
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K011623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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: 02/28/2013
• Device Model Number: 0580-1-442
• Device Catalogue Number: 0580-1-442
• Device Lot Number: G2489276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2008
• 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: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male