MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6260-9-240

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348); Joint Dislocation (2374); Reaction (2414)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Revision of the total hip.The doctor removed everything except the cup.The reasons for the revision are pain and dislocation with severe metallosis in the hip.The trunnion had completely flattened out and the head was unstable.

Manufacturer Narrative

An event regarding dislocation 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: a review of the provided office notes, primary and revision operative reports and x-rays by a clinical consultant indicated: ¿there is no examination of the explanted components, no histopathology report from the revision surgery, no dated serial x-rays or documented follow-up for the period between (b)(6) 2010 and (b)(6) 2016.Based upon the information available for review, no determination can be made for the cause of the clinical event described resulting in the (b)(6) 2016 right hip revision surgery.¿ -device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.This event was determined to be within the scope of ra 2016-028.Conclusions: the subject device has been identified to be within scope of an nc and a capa.Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads within scope of 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.Product surveillance will continue to monitor for trends.

Event Description

Revision of the total hip.The dr.Removed everything except the cup.The reasons for the revision are pain and dislocation with severe metallosis in the hip.The trunnion had completely flattened out and the head was unstable.

• Brand Name: V40 COCR LFIT HEAD 40MM/+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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5904010
• MDR Text Key: 52993523
• Report Number: 0002249697-2016-02772
• 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: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2010
• Device Catalogue Number: 6260-9-240
• Device Lot Number: MJA73M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2010
• 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): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 122