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

Device Problems Corroded (1131); Degraded (1153)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Cancer (3262)

Event Date 06/23/2022

Event Type  Injury  

Event 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 296130224
• Report Number: 0002249697-2022-01034
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327016321
• UDI-Public: 07613327016321
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K910988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 71 KG