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

Catalog Number 6260-9-136

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Injury (2348)

Event Date 12/19/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient underwent a total hip (b)(6) 2006 with trident cup, x3 poly, accolade stem, lfit v40 head.The patient recently had been experiencing increasing pain/clicking and reported to er.X ray revealed that the head was disassociated from the stem and revision surgery was scheduled.The stem, head, and liner were removed and replaced with a restoration modular stem, biolox delta head, troch plate, and new x3 liner.

Manufacturer Narrative

An event regarding disassociation involving a v40 lfit head was reported.The event was confirmed.Method & results: -device evaluation and results: ¿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.Scratches were observed on the insert, which is a common damage mode of uhmwpe.Yellow discoloration consistent with absorption of synovial fluid was also observed on the insert.No material or manufacturing defects were observed on the surfaces examined.¿ -medical records received and evaluation: ¿x-ray printouts include an undated ap of the pelvis and ap of the right hip, labeled ¿erect¿, demonstrating an uncemented right total hip arthroplasty with one screw in the acetabulum.The hip is reduced in nominal position and no heterotopic ossification is noted.Another undated ap of the pelvis and ap and lateral of the right hip notes the same arthroplasty with a disassociated head/trunnion with the head dislocated from the acetabulum.The stem and acetabular shell appear unchanged and well-fixed, and brooker iii heterotopic ossification is noted.¿ ¿no patient demographics, no clinical or past medical history, and no dated serial x-rays are available for review.Based upon the information available, no determination can be made regarding the cause of the event ten years post implantation requiring revision surgery of the right total hip arthroplasty.¿ -device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusions: the investigation concluded that the head and stem disassociated.According to the mar analysis, ¿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 material or manufacturing defects were observed on the surfaces examined.¿ the review by a clinician stated, ¿another undated ap of the pelvis and ap and lateral of the right hip notes the same arthroplasty with a disassociated head/trunnion with the head dislocated from the acetabulum.No patient demographics, no clinical or past medical history, and no dated serial x-rays are available for review.Based upon the information available, no determination can be made regarding the cause of the event ten years post implantation requiring revision surgery of the right total hip arthroplasty.¿.

Event Description

Patient underwent a total hip (b)(6) 2006 with trident cup, x3 poly, accolade stem, lfit v40 head.The patient recently had been experiencing increasing pain/clicking and reported to er.X ray revealed that the head was disassociated from the stem and revision surgery was scheduled.The stem, head, and liner were removed and replaced with a restoration modular stem, biolox delta head, troch plate, and new x3 liner.

Manufacturer Narrative

An event regarding disassociation involving a v40 lfit head was reported.The event was confirmed.Method & results: device evaluation and results: ¿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.Scratches were observed on the insert, which is a common damage mode of uhmwpe.Yellow discoloration consistent with absorption of synovial fluid was also observed on the insert.No material or manufacturing defects were observed on the surfaces examined.¿ medical records received and evaluation: ¿x-ray printouts include an undated ap of the pelvis and ap of the right hip, labeled ¿erect¿, demonstrating an uncemented right total hip arthroplasty with one screw in the acetabulum.The hip is reduced in nominal position and no heterotopic ossification is noted.Another undated ap of the pelvis and ap and lateral of the right hip notes the same arthroplasty with a disassociated head/trunnion with the head dislocated from the acetabulum.The stem and acetabular shell appear unchanged and well-fixed, and brooker iii heterotopic ossification is noted.¿ ¿no patient demographics, no clinical or past medical history, and no dated serial x-rays are available for review.Based upon the information available, no determination can be made regarding the cause of the event ten years post implantation requiring revision surgery of the right total hip arthroplasty.¿ device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the investigation concluded that the head and stem disassociated.According to the mar analysis, ¿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 material or manufacturing defects were observed on the surfaces examined.¿ the review by a clinician stated, ¿another undated ap of the pelvis and ap and lateral of the right hip notes the same arthroplasty with a disassociated head/trunnion with the head dislocated from the acetabulum.No patient demographics, no clinical or past medical history, and no dated serial x-rays are available for review.Based upon the information available, no determination can be made regarding the cause of the event ten years post implantation requiring revision surgery of the right total hip arthroplasty.¿ 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

Patient underwent a total hip (b)(6) 2006 with trident cup, x3 poly, accolade stem, lfit v40 head.The patient recently had been experiencing increasing pain/clicking and reported to er.X ray revealed that the head was disassociated from the stem and revision surgery was scheduled.The stem, head, and liner were removed and replaced with a restoration modular stem, biolox delta head, troch plate, and new x3 liner.

• 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: 6254210
• MDR Text Key: 64901225
• Report Number: 0002249697-2017-00221
• 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: 05/30/2018

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: 08/22/2011
• Device Catalogue Number: 6260-9-136
• Device Lot Number: 19549601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/16/2017
• Supplement Dates Manufacturer Received: Not provided; 05/04/2018
• Supplement Dates FDA Received: 05/16/2017; 05/30/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 80 YR