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

Catalog Number 6260-9-244

Device Problem Corroded (1131)

Patient Problems Pain (1994); Injury (2348); Reaction (2414)

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

Although the lot code was not provided, the event details, catalog number and date of implant are all in scope of ra 2016-028 therefore, this device is being assessed as under the scope of the recall.Conclusion: 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 evaluated by manufacturer? not returned to the manufacturer.

Event Description

It was reported that the patient's right hip was revised.After patient complaint of pain, diagnostics revealed elevated serum ion levels in the patient's blood.Intra-operatively, some corrosion was noted inside the femoral head.The femoral head was revised to a sleeve with ceramic head.The stem was not revised as the trunnion was intact.Rep reported that no further information will be released by the hospital or surgeon.

• Brand Name: V40 COCR LFIT HEAD 44MM/+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: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9532017
• MDR Text Key: 185709659
• Report Number: 0002249697-2019-04135
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032758
• UDI-Public: 07613327032758
• 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: 12/30/2019

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 Catalogue Number: 6260-9-244
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 64 YR