MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 44MM/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6260-9-244

Device Problems Nonstandard Device (1420); Defective Component (2292); Device Dislodged or Dislocated (2923); Manufacturing, Packaging or Shipping Problem (2975); Scratched Material (3020)

Patient Problems Pain (1994); Injury (2348); Ambulation Difficulties (2544)

Event Date 09/27/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

V40 head recall.Patient had a 44 +4 v40 head that was listed on the recent v40 recall.Surgeon performed revision surgery to explant affected v40 head and stem.The 44 +4 head, accolade tmzf size 5 stem and 44g poly explanted.Restoration modular and mdm re-implanted.The patient was no longer able to walk on their replaced total hip.The initial plan was to revise the total hip in (b)(6), however over the past weekend the patient called and told the surgeon he could no longer stand or walk.The pain began once the patient could no longer walk.

Manufacturer Narrative

An event regarding disassociation involving a lfit v40 cocr head that was mated with accolade tmzf stem and trident liner was reported.The event was confirmed.Method & results: -device evaluation and results: there are scratches in the hole and base of the head.There is also discoloration at the top of the head.Material analysis was not performed as this falls under the scope of recall ra 2016-028.-medical records received and evaluation: the provided medical information was submitted to a consulting clinician who deemed it insufficient for a medical review.¿the x-ray confirm shows disassociation of head and stem, need operative reports, clinical and past medical history, and need dated x-rays.¿ -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 has been no other event reported for the lot code.This event was determined to be within the scope of ra 2016-028.Conclusions: lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads within the scope the 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 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

V40 head recall.Patient had a 44 +4 v40 head that was listed on the recent v40 recall.Surgeon performed revision surgery to explant affected v40 head and stem.44 +4 head, accolade tmzf size 5 stem and 44g poly explanted.Restoration modular and mdm re-implanted.The patient was no longer able to walk on their replaced total hip.The initial plan was to revise the total hip in october, however over the past weekend the patient called and told the surgeon he could no longer stand or walk.The pain began once the patient could no longer walk.

• Brand Name: V40 COCR LFIT HEAD 44MM/+4
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6056736
• MDR Text Key: 58400940
• Report Number: 0002249697-2016-03368
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2012
• Device Catalogue Number: 6260-9-244
• Device Lot Number: TRNMMD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 102