MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28MM +12 5-40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6264-5-428

Device Problem Unstable (1667)

Patient Problem Insufficient Information (4580)

Event Date 01/25/2011

Event Type  Injury  

Event Description

Medical records received from legal indicated patient had a revision of the femoral head for unknown reasons.

Manufacturer Narrative

An event regarding instability 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.Clinician review: a review of medical records with a clinical consultant indicate " this case concerns a gentleman who underwent an index total hip arthroplasty in 2001, a revision arthroplasty in 2011 for recurrent instability, and yet another revision in 2018 for elevated chromium and cobalt levels, trunnionosis and what appears to be pseudotumors.I cannot confirm the index surgery in 2001 since i only have documentation of this in a surgical operation report.I can confirm that the patient had a revision using a constrained liner with a +12 femoral head in 2011.I can also confirm that the patient underwent another revision in 2018 for elevated chromium and cobalt levels and trunnionosis.The root cause of recurrent instability is multifactorial and cannot be determined with certainty.Contributing factors include surgical technique factors including improper positioning of the implants, failure to restore the proper soft tissue tension in the thigh and possible impingement issues.Patient activity level and lifestyle, as well as bmi can also contribute.Instability can occur when there is stretching of the capsular tissues with loss of the normal periarticular constraints.Unless polyethylene wear was found or some other mechanical issue, i would not assign any causality to the implant itself for recurrent instability.The root causes of trunnionosis with elevated chromium and cobalt levels cannot be determined with certainty.Possible factors can be surgical technique including restoration of proper mechanics, and proper preparation of the trunnion before insertion of the femoral head.Along with the offset of the femoral implant, the use of a +12 mm neck length in my opinion can also possibly contribute to the development of corrosion but this has not been proven.Patient factors including activity level, lifestyle and bmi can also contribute.[.] 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 was revised due to instability.A review of medical records with a clinical consultant indicate " this case concerns a gentleman who underwent an index total hip arthroplasty in 2001, a revision arthroplasty in 2011 for recurrent instability, and yet another revision in 2018 for elevated chromium and cobalt levels, trunnionosis and what appears to be pseudotumors.I cannot confirm the index surgery in 2001 since i only have documentation of this in a surgical operation report.I can confirm that the patient had a revision using a constrained liner with a +12 femoral head in 2011.I can also confirm that the patient underwent another revision in 2018 for elevated chromium and cobalt levels and trunnionosis.The root cause of recurrent instability is multifactorial and cannot be determined with certainty.Contributing factors include surgical technique factors including improper positioning of the implants, failure to restore the proper soft tissue tension in the thigh and possible impingement issues.Patient activity level and lifestyle, as well as bmi can also contribute.Instability can occur when there is stretching of the capsular tissues with loss of the normal periarticular constraints.Unless polyethylene wear was found or some other mechanical issue, i would not assign any causality to the implant itself for recurrent instability.The root causes of trunnionosis with elevated chromium and cobalt levels cannot be determined with certainty.Possible factors can be surgical technique including restoration of proper mechanics, and proper preparation of the trunnion before insertion of the femoral head.Along with the offset of the femoral implant, the use of a +12 mm neck length in my opinion can also possibly contribute to the development of corrosion but this has not been proven.Patient factors including activity level, lifestyle and bmi can also contribute.[.]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.H3 other text : device not returned to the manufacturer.

• Brand Name: 28MM +12 5-40 TAPER VIT HEAD
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18031004
• MDR Text Key: 326866118
• Report Number: 0002249697-2023-01277
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K936127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2004
• Device Catalogue Number: 6264-5-428
• Device Lot Number: CAGCT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/1999
• 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: 63 YR
• Patient Sex: Male