MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 6260-9-136

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

Patient Problems Ossification (1428); Bone Fracture(s) (1870); Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544); Joint Laxity (4526); Muscle/Tendon Damage (4532); Insufficient Information (4580)

Event Date 09/06/2022

Event Type  Injury  

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.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.Device not returned to the manufacturer.

Event Description

Wife reported her husband had a revision of the left hip on (b)(6), 2022 due to the "two metals being worn down to fine pencil tips".Primary surgery was done in (b)(6) 2007.

Event Description

Wife reported her husband had a revision of the left hip on (b)(6) 2022 due to the "two metals being worn down to fine pencil tips".Primary surgery was done in (b)(6) 2007.Update: per patient medical records, it was indicated that the patient was revised due to disassociation of the head from the stem, fracture of the femoral stem trunnion, metallosis and osteolysis, destruction of abductors, heterotopic ossification and fracture of the greater trochanter whereby the stem, head and liner were explanted and the patient was converted to a restoration modular construct with dalle miles grip plate and cabling for fixation.It was also reported that the shell was slightly more vertical than ideal but removal would have caused significant bone loss, so it was left implanted.During revision surgery, the following were performed: "debridement of chronic metallic wear debris and osteolysis," "open reduction internal fixation left greater trochanter fracture," and "resection of heterotopic ossification." despite the reported proximal bone erosions, the femoral stem was reported to be well-fixed and removal was intensive.

Manufacturer Narrative

Reported event: an event regarding disassociation and wear/metallosis involving a lfit v40 cocr head that was mated with a citation stem was reported.The event was confirmed via clinician review of provided medical records.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: "conclusion/assessment: the patient underwent a tha with a citation tmzf stem matched to a v40 lfit 36 mm head in 2007.In 2022, he had a catastrophic failure of the femoral stem with a trunnion fracture.He underwent a revision tha.Event confirmation: the event, a revision for fracture of the femoral stem was confirmed.Root cause: the root cause of the revision was fracture of the femoral stem.The root cause of the stem fracture cannot be stated." -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 disassociation of the head from the stem, fracture of the stem trunnion, and metallosis around the joint due to metallic debris.The subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall pfa (b)(4) 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 on or before march 4, 2011.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.

• Brand Name: V40 COCR LFIT HEAD 36MM/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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16590153
• MDR Text Key: 311774324
• Report Number: 0002249697-2023-00288
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032307
• UDI-Public: 07613327032307
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• 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: 6260-9-136
• Device Catalogue Number: 6260-9-136
• Device Lot Number: V7NMAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2007
• 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): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White