MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +8 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-5-332
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported revision surgery was required as it was identified through x rays that the head had disassociated from the trunnion.It was further reported that the original implant surgery was approximately 10 years prior.
Additional Manufacturer Narrative
Reported event an event regarding disassociation involving a metal head was reported.The event was confirmed through visual inspection of the part where it was identified that the taper lock was compromised.Method & results -product evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted metal head.From the photographs provided there is evidence of the presence of biological material, however, a photograph of the taper of the head was not provided.The associated stem had trunnion wear, which is consistent with the loss of taper lock.The lot number of the head was not visible.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of the device history records could not be performed as lot code information was unknown.-complaint history review: a complaint history review could not be performed as lot code information was unknown.Conclusions: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted metal head.From the photographs provided there is evidence of the presence of biological material, however, a photograph of the taper of the head was not provided.The associated stem had trunnion wear, which is consistent with the loss of taper lock.If further information becomes available or the product is returned, this investigation will be re-opened.H3 other text : device not returned.
Additional Manufacturer Narrative
Reported event an event regarding disassociation involving a metal head was reported.The event was confirmed through visual inspection of the part where it was identified that the taper lock was compromised.Method & results -product evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted metal head.From the photographs provided there is evidence of the presence of biological material, however, a photograph of the taper of the head was not provided.The associated stem had trunnion wear, which is consistent with the loss of taper lock.The lot number of the head was not visible.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of the device history records could not be performed as lot code information was unknown.-complaint history review: a complaint history review could not be performed as lot code information was unknown.Conclusions: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted metal head.From the photographs provided there is evidence of the presence of biological material, however, a photograph of the taper of the head was not provided.The associated stem had trunnion wear, which is consistent with the loss of taper lock.
Event or Problem Description
It was reported revision surgery was required as it was identified through x rays that the head had disassociated from the trunnion.It was further reported that the original implant surgery was approximately 10 years prior.

• Brand Name: 32MM +8 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: brad curtis ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16820453
• Report Number: 0002249697-2023-00427
• Device Sequence Number: 12557936
• Product Code: JDI
• UDI-Device Identifier: 07613327012934
• UDI-Public: 07613327012934
• 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: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

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 Model Number: 6260-5-332
• Device Catalogue Number: 6260-5-332
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Male