MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM STD V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-5-132
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	07/14/2022
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.
Event or Problem Description
"trunnionosis stem brace 2 and metal head 32mm +4mm.".
Event or Problem Description
"trunnionosis stem brace 2 and metal head 32mm +4mm.".
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a metal head was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection: damage was observed on the head taper.This damage was consistent with the interaction between the head taper and stem trunnion.Slight debris was observed on the articulating surface and taper of the head.Explantation damage observed.Dimensional inspection was not performed because the device was returned damaged.Functional inspection was not performed because the event does not relate to device function.Material analysis not performed as visual inspection provided no indication that the event was a result of a material integrity issue.If further information becomes available additional testing will be performed.Clinician review: a review of the provided medical information by a clinical consultant indicated: "unfortunately, there is little documentation for either of these inquiries and no office notes, operation notes or any other documentation was provided.It appears that either one patient had bilateral total hip arthroplasties, or these inquiries may concern two separate patients.I cannot confirm that any of these events occurred since there is no supporting documentation.In addition, the pi reporting is incomplete without documentation.There is mention that trunnionosis was involved in both of these inquiries which led to revision.The causes of trunnionosis are multifactorial including surgical technique factors such as proper assembly and preparation of the implants, as well as implantation, positioning, orientation, and fixation.Patient factors may also be involved including bmi and activity level, as well as implant factors." 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 trunnionosis.Visual inspection of the returned device indicated damage was observed on the head taper.This damage was consistent with the interaction between the head taper and stem trunnion.Slight debris was observed on the articulating surface and taper of the head.Explantation damage observed."unfortunately, there is little documentation for either of these inquiries and no office notes, operation notes or any other documentation was provided.It appears that either one patient had bilateral total hip arthroplasties, or these inquiries may concern two separate patients.I cannot confirm that any of these events occurred since there is no supporting documentation.In addition, the pi reporting is incomplete without documentation.There is mention that trunnionosis was involved in both of these inquiries which led to revision.The causes of trunnionosis are multifactorial including surgical technique factors such as proper assembly and preparation of the implants, as well as implantation, positioning, orientation, and fixation.Patient factors may also be involved including bmi and activity level, as well as implant factors." no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: 32MM STD V40 TAPER VIT HEAD
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 15154585
• Report Number: 0002249697-2022-01139
• Device Sequence Number: 5208691
• Product Code: JDI
• UDI-Device Identifier: 07613327012873
• UDI-Public: 07613327012873
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2022

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: 07/31/2023
• Device Model Number: 6260-5-132
• Device Catalogue Number: 6260-5-132
• Device Lot Number: 65660602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2018
• 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: Female