MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 44MM/+0; HIP IMPLANT

Catalog Number 6260-9-144

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 05/04/2016

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Left hip revision.Head was disassociated on x-ray.Everything came out.Zimmer components went in.

Manufacturer Narrative

An event regarding disassociation involving an unknown femoral head and unknown accolade stem was reported.This was confirmed following a review by a clinical consultant.Possible altr was also discussed by the clinical consultant this was not confirmed.Method & 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: cup malposition in absent anteversion plus medialized position with possibly also some heterotopic ossifications and patient obesity have contributed to an overload condition is the arthroplasty with catastrophic trunnion failure requiring revision.Conclusions: a review by a clinical consultant concluded: "cup malposition in absent anteversion plus medialized position with possibly also some heterotopic ossifications and patient obesity have contributed to an overload condition is the arthroplasty with catastrophic trunnion failure requiring revision" no further investigation for this event is possible at this time.Further information such as device details, return of device, operative reports, & 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

Left hip revision.Head was disassociated on x-ray.Everything came out.Zimmer components went in.

Manufacturer Narrative

An event regarding disassociation involving an v40 cocr lfit head 44mm/+0 and accolade plus tmzf hip stem #5 was reported.This was confirmed following a review by a clinical consultant.Method and results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar).Damage was observed on the accolade trunnion and v40 head taper.This damage was consistent with wear mechanisms due to the head taper and accolade stem trunnion losing their taper lock.No root cause of the loss of taper lock could be determined.No material or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: a review by a clinical consultant noted: "cup malposition in absent anteversion plus medialized position with possibly also some heterotopic ossifications and patient obesity have contributed to an overload condition is the arthroplasty with catastrophic trunnion failure requiring revision." device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: a review by a clinical consultant concluded: "cup malposition in absent anteversion plus medialized position with possibly also some heterotopic ossifications and patient obesity have contributed to an overload condition is the arthroplasty with catastrophic trunnion failure requiring revision" no further investigation for this event is possible at this time.Further information including operative reports, and follow-up notes are needed to investigate this event further.If additional information become available, this investigation will be reopened.

Event Description

Left hip revision.Head was disassociated on x-ray.Everything came out.Zimmer components went in.

Manufacturer Narrative

Corrected data: expiration date.Additional information: remedial action initiated; correction/removal rpt number.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 (b)(6)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

Left hip revision.Head was disassociated on x-ray.Everything came out.Zimmer components went in.

• Brand Name: V40 COCR LFIT HEAD 44MM/+0
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 5689377
• MDR Text Key: 46252483
• Report Number: 0002249697-2016-01764
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K061434
• 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,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: 08/31/2011
• Device Catalogue Number: 6260-9-144
• Device Lot Number: 1XAMMA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Initial Date Manufacturer Received: 05/04/2016
• Initial Date FDA Received: 05/31/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 05/04/2018
• Supplement Dates FDA Received: 07/09/2016; 09/23/2016; 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: 61 YR
• Patient Weight: 119