MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+10; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-336

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 02/16/2016

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested and if received, will be provided in the supplemental report.

Event Description

It was reported that surgeon revised patient's right hip.The hip was implanted 11 years ago and was an accolade tmzf stem revised due to dislocation caused by trunnionosis.It was noted on explant that the trunnion was bent as a result of the trunnionosis and patient dislocated as a result.Surgeon removed the stem, head and liner.Revised stem and head and liner - cup remained - revised with competitor stem, head and stryker liner.

Manufacturer Narrative

An event regarding disassociation involving a metal head was reported.This was confirmed following a review by a clinical consultant.Method and results: device evaluation and results: a visual, dimensional and functional inspection was not performed as the device was not returned for evaluation.Medical records received and evaluation: a review by a clinical consultant noted: despite the somewhat limited clinical and radiological information, it is clear that the cup has significant malposition in absent ante version which is very relevant to the failure mechanism of this case.Conclusions: a review by a clinical consultant concluded: cup malposition in absent ante version has contributed to overload in the bearing section of the arthroplasty causing excessive micro motion between stem taper and femoral head leading to catastrophic taper damage as final effect with dissociation of the femoral head from the taper requiring revision.No further investigation for this event is possible at this time.Further information such as device details, return of device, operative reports, x rays, patient history and follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

It was reported that surgeon revised patient's right hip.The hip was implanted 11 years ago and was an accolade tmzf stem revised due to dislocation caused by trunnionosis.It was noted on explant that the trunnion was bent as a result of the trunnionosis and patient dislocated as a result.Surgeon removed the stem, head and liner.Revised stem and head and liner - cup remained - revised with competitor stem, head and stryker liner.

Event Description

It was reported that surgeon revised patient's right hip.The hip was implanted 11 years ago and was an accolade tmzf stem revised due to dislocation caused by trunnionosis.It was noted on explant that the trunnion was bent as a result of the trunnionosis and patient dislocated as a result.Surgeon removed the stem, head and liner.Revised stem and head and liner - cup remained - revised with competitor stem, head and stryker liner.

Manufacturer Narrative

Additional information: age at time of event; brand name; product code; common device name; catalog #; lot #, expiration date; pma/510(k) #;and device manufacture date.An event regarding disassociation involving a metal head was reported.The event was confirmed by medical review.Method & results: -product evaluation and results: a visual, dimensional and functional inspection was not performed as the device was not returned for evaluation -clinician review: a review by a clinical consultant noted: despite the somewhat limited clinical and radiological information, it is clear that the cup has significant malposition in absent anteversion which is very relevant to the failure mechanism of this case.-product history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review indicated there have been no other events for the reported lot.Conclusions: the event was confirmed by medical review.A review by a clinical consultant concluded: cup malposition in absent anteversion has contributed to overload in the bearing section of the arthroplasty causing excessive micro motion between stem taper and femoral head leading to catastrophic taper damage as final effect with dissociation of the femoral head from the taper requiring revision.No further investigation for this event is possible at this time.Further information such as device details, return of device, operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.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.

• Brand Name: V40 COCR LFIT HEAD 36MM/+10
• 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: 5493713
• MDR Text Key: 40118994
• Report Number: 0002249697-2016-00769
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2018

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: 09/30/2010
• Device Catalogue Number: 6260-9-336
• Device Lot Number: 33678202
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2016
• Initial Date FDA Received: 03/10/2016
• Supplement Dates Manufacturer Received: Not provided; 05/04/2018
• Supplement Dates FDA Received: 05/03/2016; 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2249697-05-07-2018-003-R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR