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); Material Erosion (1214)

Patient Problems Inflammation (1932); Discomfort (2330); Metal Related Pathology (4530)

Event Date 02/16/2021

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 other similar events for the lot referenced.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.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.

Event Description

The following was reported: the patient has massive taper wear of the hip stem after cementless hip arthroplasty 2006 left (accolade stem size 4.5, v40 metal head 36mm m lot 38449802c, trident cup size 52 e lot 17796801, pe inlay 0° 36e lot 9dxmea) due to this, a complete exchange of the hip endoprosthesis due to pronounced metallosis and discomfort.The diagnosis could first be radiologically confirmed on (b)(6).2020.A previously performed x-ray control from the year 2017 was unremarkable.

Manufacturer Narrative

Reported event:  an event regarding wear involving a metal head was reported. the event was not confirmed method & results:  device evaluation and results: visual inspection: visual inspection was performed as part of the material evaluation and indicated the following comments: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.This has been documented as part of capa.No further material analyses were performed.Ma: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.This has been documented as part of capa.No further material analyses were performed.Functional inspection: not performed as the functional aspects are not in question.Dimensional inspection: not performed as the device was returned in damaged state.Clinician review: the provided x-ray/ medical reports were rejected for medical review by our clinical consultant and stated that: (b)(6) 2017 x-rays ap pelvis, lat right hip, lat.Left hip: bilateral uncemented tha both reduced, nominal with no evidence of gross pathology.(b)(6) 2020 ap pelvis, lat.Right hip, lat.Left hip both hips same tha with periarticular radiodensities, hips reduced but trunnions not confirmed to be centered in modular heads.No clinical or pmh, no examination of explanted components, no laboratory or surgical pathology reports.While the information available for review appears to confirm both event descriptions, insufficient data is present to create a medical report for this patient.Device history review: all 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 reported lot.Conclusion:  the subject device has been identified to be within the scope of lot specific voluntary recall initiated for the lfit v40 cocr heads.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.

Event Description

The following was reported: the patient has massive taper wear of the hip stem after cementless hip arthroplasty 2006 left (accolade stem size 4.5, v40 metal head 36mm m lot 38449802c, trident cup size 52 e lot 17796801, pe inlay 0° 36e lot 9dxmea) due to this, a complete exchange of the hip endoprosthesis due to pronounced metallosis and discomfort.The diagnosis could first be radiologically confirmed on 18.02.2020.A previously performed x-ray control from the year 2017 was unremarkable.

• 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
• MDR Report Key: 11556100
• MDR Text Key: 257167639
• Report Number: 0002249697-2021-00520
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032307
• UDI-Public: 07613327032307
• Combination Product (y/n): N
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

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: 02/28/2011
• Device Model Number: 6260-9-136
• Device Catalogue Number: 6260-9-136
• Device Lot Number: 38449802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 07/28/2021
• Supplement Dates FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2249697-05/07/2018-003R
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 76