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

Model Number 06-3205

Device Problems Degraded (1153); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2022

Event Type  Injury  

Event Description

It was reported that the patient's left hip was revised due to trunnionosis, gross trunnion failure, and dissociation of the head from the stem.The stem, head, and competitor liner were revised to competitor implants.

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.

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.

Event Description

It was reported that the patient's left hip was revised due to trunnionosis, gross trunnion failure, and dissociation of the head from the stem.The stem, head, and competitor liner were revised to competitor implants.

Manufacturer Narrative

Reported event an event regarding disassociation involving a metal head was reported.The event was confirmed via clinician review.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: what can be gleaned from the limited information provided is that a primary securefit max 11/15 and c taper cocr head 32+5 was revised for extensive trunnionosis and dissociation of the femoral head from the stem.A single ap x-ray of the hip was provided.This demonstrated severe remodeling of the trunnion with dissociation of the femoral head.No supporting information was available to establish the root cause for this issue.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's hip was revised due to trunnionosis, gross trunnion failure, and dissociation of the head from the stem.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports 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's left hip was revised due to trunnionosis, gross trunnion failure, and dissociation of the head from the stem.The stem, head, and competitor liner were revised to competitor implants.

• Brand Name: C-TAPER COCR LFIT HEAD 32MM/+5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• 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: 13392142
• MDR Text Key: 285625778
• Report Number: 0002249697-2022-00141
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 07613327016321
• UDI-Public: 07613327016321
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2011
• Device Model Number: 06-3205
• Device Catalogue Number: 06-3205
• Device Lot Number: N1EMDA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2006
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR