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

Catalog Number 6260-9-040

Device Problems Malposition of Device (2616); Noise, Audible (3273)

Patient Problems Arthritis (1723); Pain (1994)

Event Date 09/16/2019

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.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.Device not returned.

Event Description

Patient returned to dr's office to ask the pain in his left hip due to arthritis.During this appointment the patient stated his right hip has started clicking but was not painful.While examining the radiograph dr noticed the trunnions was not in the center of the implant head.It looked eccentric.A revision surgery was then scheduled.

• Brand Name: V40 COCR LFIT HEAD 40MM/-4
• 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: collin neitzel ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9186215
• MDR Text Key: 170041131
• Report Number: 0002249697-2019-03486
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032703
• UDI-Public: 07613327032703
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173499
• 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
• Report Date: 10/14/2019

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: 07/31/2014
• Device Catalogue Number: 6260-9-040
• Device Lot Number: MHKD8X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2249697-05/07/2018-003R
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR