MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28MM -4 V40 TAPER VIT HEAD; HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS

Model Number 6260-5-028

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2014

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Lot specific voluntary recall was initiated for the v40 heads within scope of a capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action.The root cause analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted, removed from the field and/or expired.

Event Description

Patient called stating she had a left hip replacement done (b)(6) 2014, she would like to know if her implants were involved in a recall.Patient is asymptomatic at the time of this call.

• Brand Name: 28MM -4 V40 TAPER VIT HEAD
• Type of Device: HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; IE NA
• Manufacturer Contact: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 9972630
• MDR Text Key: 188198838
• Report Number: 0002249697-2020-00757
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327012835
• UDI-Public: 07613327012835
• 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: consumer,other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 6260-5-028
• Device Catalogue Number: 6260-5-028
• Device Lot Number: 48781104
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0261-2016
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 72