MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+12; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6260-9-440

Device Problems Break (1069); Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Pain (1994); Injury (2348)

Event Date 03/20/2014

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs.No additional information is available at this time due to ongoing litigation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported that there was a revision of a right broken trunnion on the stem.Head and stem were revised.During the revision surgery while trying to extract the stem the impactor adapter broke.Update as per legal, doa (b)(4) 2016: it is reported by counsel that the patient underwent a rtha with a meridian stem and an lfit 40mm +12 head on (b)(6) 2009.The patient experienced pain and x-rays showed that the meridian stem fractured.The surgeon believed issue could also be taper lock failure where the head and neck became disengaged.The patient was revised on 3/20/14; the revision operative report confirmed fracture of the stem and the neck/head junction.The patient, through counsel, demands compensation for his alleged injury.

Event Description

It was reported that there was a revision of a right broken trunnion on the stem.Head and stem were revised.During the revision surgery while trying to extract the stem the impactor adapter broke.Update as per legal: it is reported by counsel that the patient underwent a rtha with a meridian stem and an lfit 40mm +12 head on (b)(6) 2009.The patient experienced pain and x-rays showed that the meridian stem fractured.The surgeon believed issue could also be taper lock failure where the head and neck became disengaged.The patient was revised on (b)(6) 2014; the revision operative report confirmed fracture of the stem and the neck/head junction.The patient, through counsel, demands compensation for his alleged injury.

Manufacturer Narrative

An event regarding alleged disassociation involving a metal head was reported.The event was not confirmed.Method & results: device evaluation and results: could not be performed as no items associated with the event were returned for evaluation.Medical records received and evaluation: the provided medical records were reviewed by a consulting clinician who indicated a medical review could not be performed as additional records such as clinical information, x-rays and revision operative reports are required.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: the reported event was not confirmed.However, the subject device has been identified to be within scope of a recall.Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads.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.If further information becomes available and/or the product is returned, this investigation will be re-opened.

• Brand Name: V40 COCR LFIT HEAD 40MM/+12
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 5919771
• MDR Text Key: 53661344
• Report Number: 0002249697-2016-02827
• 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
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 6260-9-440
• Device Lot Number: 4EWMHE
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 122