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
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/09/2014
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9972630
• Report Number: 0002249697-2020-00757
• Device Sequence Number: 3775965
• Product Code: JDI
• UDI-Device Identifier: 07613327012835
• UDI-Public: 07613327012835
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0261-2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Weight: 72