MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-140

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

Patient Problems Foreign Body Reaction (1868); Metal Related Pathology (4530); Insufficient Information (4580)

Event Date 11/20/2023

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.H3 other text : device not returned.

Event Description

It was reported that the patient's right hip was revised due to trunnionosis and metallosis.Intra-operatively, the following were noted: trunnion wear, femoral head was loose yet wedged on the trunnion, black tissue in the patient.The stem, head, and liner were revised (there were no allegations against the revised liner).Rep can provide pictures and otherwise confirmed that no further information is available from the hospital or surgeon.

Manufacturer Narrative

An event regarding altr and wear involving a metal head was reported.The event was confirmed via evaluation of the provided photographs.Method & results: -product evaluation and results: the reported device was not returned however a photograph of the stem, head and liner was provided for review.Visual inspection of the provided photograph indicated that the devices are covered in blood.The stem has what appears to be black tissue on its body and is severely worn consistent with loss of taper lock.The liner has damage sustained from explantation.-clinician review: no medical records were provided for review with a clinical consultant.-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 trunnionosis, metallosis and altr.The subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of nc and capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured.The root cause analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.

Event Description

It was reported that the patient's right hip was revised due to trunnionosis and metallosis.Intra-operatively, the following were noted: trunnion wear, femoral head was loose yet wedged on the trunnion, black tissue in the patient.The stem, head, and liner were revised (there were no allegations against the revised liner).Rep can provide pictures and otherwise confirmed that no further information is available from the hospital or surgeon.

• Brand Name: V40 COCR LFIT HEAD 40MM/+0
• 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: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18307669
• MDR Text Key: 330226798
• Report Number: 0002249697-2023-01533
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032727
• UDI-Public: 07613327032727
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

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: 08/31/2015
• Device Catalogue Number: 6260-9-140
• Device Lot Number: MJLM5W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 02/17/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2249697-05/07/2018-003R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 84 KG