MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-236

Device Problems Break (1069); Detachment Of Device Component (1104); Mechanical Problem (1384); Detachment of Device or Device Component (2907); Manufacturing, Packaging or Shipping Problem (2975); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Inflammation (1932); Injury (2348)

Event Date 01/11/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient was scheduled for incision and drainage with possible head and poly exchange.After exposure trunnion was noticeably worn and femoral head was no longer engaged.The inserter (1020-1600) tip broke off inside the accolade stem.Poly and head exchange became total hip revision with extended trochanteric osteotomy due to stem inserter breaking.Case turned into hip revision because the implanted hip stem was not usable.Attempted to extract the stem.

Manufacturer Narrative

An event regarding disassociation involving a metal head was reported.The event was confirmed.Method & results: -device evaluation and results: a material analysis has been performed.The report concluded: "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.A fractured inserter/extractor was observed in the stem.The fracture was consistent with an overload condition.Eds showed the inserter/extractor was consistent with (b)(4).No material or manufacturing defects were observed on the surfaces examined." -medical records received and evaluation: no patient medical records were available for review.-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 3 other similar events for the reported lot.Conclusions: the subject device has been identified to be within scope of (b)(4) and capa (b)(4).Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads within scope of (b)(4) and capa (b)(4).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

Patient was scheduled for incision and drainage with possible head and poly exchange.After exposure trunnion was noticeably worn and femoral head was no longer engaged.The inserter (1020-1600) tip broke off inside the accolade stem.Poly and head exchange became total hip revision with extended trochanteric osteotomy due to stem inserter breaking.Case turned into hip revision because the implanted hip stem was not usable.Attempted to extract the stem.

• Brand Name: V40 COCR LFIT HEAD 36MM/+5
• 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: suzanne neuschwanter ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6307200
• MDR Text Key: 66709156
• Report Number: 0002249697-2017-00476
• Device Sequence Number: 1
• Product Code: JDI
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

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: 09/30/2011
• Device Catalogue Number: 6260-9-236
• Device Lot Number: 19865905
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 102