MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 32MM/+5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	06-3205
Medical Device Problem Codes	Corroded (1131); Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Cancer (3262)
Date of Event	06/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a primary total hip arthroplasty with surefit stem and 32 mm +5 head and trident cup.The patient later presented with a painful right hip and required a revision due to possible trunnionosis and possible pseudotumor.Initial reporter confirmed trunnionosis was present & pseudotumor was sent to pathology for analysis.
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.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.Device not returned to the manufacturer.
Additional Manufacturer Narrative
Reported event: an event regarding altr and fretting/trunnionosis involving a metal head was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device indicates nothing remarkable.No visible black debris.Minor scratches and dents observed consistent with explantation.Clinician review: insufficient information was provided to support a medical review.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 determined because insufficient information was provided.Further information such as return of the device, histopathology reports, pre- and post-operative x-rays and the 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 devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient underwent a primary total hip arthroplasty with surefit stem and 32 mm +5 head and trident cup.The patient later presented with a painful right hip and required a revision due to possible trunnionosis and possible pseudotumor.Initial reporter confirmed trunnionosis was present & pseudotumor was sent to pathology for analysis.

• Brand Name: C-TAPER COCR LFIT HEAD 32MM/+5
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15050781
• Report Number: 0002249697-2022-01034
• Device Sequence Number: 17348829
• Product Code: JDI
• UDI-Device Identifier: 07613327016321
• UDI-Public: 07613327016321
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K910988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

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: 02/29/2012
• Device Model Number: 06-3205
• Device Catalogue Number: 06-3205
• Device Lot Number: 809MDDX1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2007
• 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: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 71 KG