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 Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
Health Effect - Clinical Codes	Discomfort (2330); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer to health canada that patient presented with total hip arthroplasty implant failure (b)(6) 2022.Patient had original total hip arthroplasty of right hip done (b)(6) 2008.4 weeks prior (b)(6) 2022, patient noticed increased discomfort in right groin radiating down to knee, in addition to a dead leg feeling, like he couldn't move it around well and had decreased range of motion (difficulty getting in and out of car and chairs).Pain was well managed, no acute trauma to hip, and could weight bear.However; at the beginning of february, patient noticed a creaking noise and when it didn't go away he called surgeon who initially completed surgery for appointment.X-rays done and a displaced fracture through neck of femoral implant noticed.Metal alkalosis was also seen.Revision surgery of hip completed on (b)(6) 2022.".
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
It was reported by the customer to health canada that "patient presented with total hip arthroplasty implant failure ((b)(6) 2022).Patient had original total hip arthroplasty of right hip done (b)(6) 2008.4 weeks prior (b)(6) 2022, patient noticed increased discomfort in right groin radiating down to knee, in addition to a ¿dead leg¿ feeling, like he couldn't move it around well and had decreased range of motion (difficulty getting in and out of car and chairs).Pain was well managed, no acute trauma to hip, and could weight bear.However, at the beginning of february, patient noticed a creaking noise and when it didn't go away he called surgeon (who initially completed surgery) for appointment.X-rays done and a displaced fracture through neck of femoral implant noticed.Metal alkalosis was also seen.Revision surgery of hip completed on (b)(6) 2022.".
Additional Manufacturer Narrative
An event regarding abnormal ion level involving a metal head was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: 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: the event could not be confirmed as insufficient information was provided.Further information such as device identification and return, pre- and post-operative x-rays, 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 become available to indicate further evaluation is warranted, this record will be reopened.

• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15526548
• Report Number: 0002249697-2022-01422
• Device Sequence Number: 6079352
• 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: 2008
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2022

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: 05/31/2011
• Device Model Number: 6260-5-332
• Device Catalogue Number: 6260-5-332
• Device Lot Number: 18677303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2006
• 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