MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_CORK_PRODUCT; UNKNOWN HIP IMPLANT

Catalog Number UNK_SHC

Device Problems Degraded (1153); Insufficient Information (3190)

Patient Problems Injury (2348); Reaction (2414); Metal Related Pathology (4530)

Event Date 01/23/2014

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device not returned.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6) 2006 and was revised on (b)(6) 2014.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.

Manufacturer Narrative

Reported event: an event regarding abnormal ion level involving an accolade stem that was mated with an lfit v40 cocr head was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: 'i have had the opportunity to review documentation related to pi including a product inquiry summary, an implant sheet from the index 2006 tha surgery and an operative report from the revision surgery.The event description from the product inquiry summary states: it was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6) 2006 and was revised on (b)(6) 2014.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.The 2006 implant record conforms an accolade stem with 40mm metal head was implanted along with a titanium shell and polyethylene liner.The revision operative report confirmed polyethylene liner wear.It also describes a layer of "dead and mummified tissue" within the hip.The surgeon opined that he thought was a local tissue reaction caused by osteolysis.No trunnion damaged was noted following removal of the femoral head.Revision surgery is confirmed.No documentation confirming altr or elevated serum metal ions was provided.The root cause of the polyethylene wear cannot be determined from the limited documentation provided.Should additional information become available i would be happy to further this assessment.' device history review: a review of the device history records indicates devices were manufactured and accepted into final stock on with no relevant reported discrepancies.Complaint history review: no other similar events were reported for the lot.Conclusion: a review of the provided medical records by a clinical consultant indicated: ' the 2006 implant record conforms an accolade stem with 40mm metal head was implanted along with a titanium shell and polyethylene liner.The revision operative report confirmed polyethylene liner wear.It also describes a layer of "dead and mummified tissue" within the hip.The surgeon opined that he thought was a local tissue reaction caused by osteolysis.No trunnion damaged was noted following removal of the femoral head.' no further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6) 2006 and was revised on (b)(6) 2014.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.Update as per medical records received 06-oct-2023: "the patient had significant layer from almost dead and mummified tissue inside the joint, most likely due to unusual reaction to osteolysis.All these tissues were meticulously removed and irrigated.".

• Brand Name: UNKNOWN_CORK_PRODUCT
• Type of Device: UNKNOWN HIP IMPLANT
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 8404405
• MDR Text Key: 138256768
• Report Number: 0002249697-2019-01280
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2006
• 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: 63 YR
• Patient Sex: Male