MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-T UNIV 2-HOLE SHL SZ 41/54; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 103535 ti low profile screw 6.5x40mm 707940; 103534 ti low profile screw 6.5x35mm 394800; 15-103684 m2a-t univ 2-hole shl sz 41/54 056120; 103533 ti low profile screw 6.5x30mm 937120; 15-105044 m2a tpr hi carbon 41/32mm lnr 080230; 11-163688 32mm m2a hi carbon hd std nk 404450; 103206 taperloc por fmrl 12.5x145 247230.The device will not be returned for analysis, as the surgeon didn't approve for return; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 01933, 0001825034 - 2021 - 01934, 0001825034 - 2021 - 01935.

Event Description

It was reported a patient underwent a hip arthroplasty approximately 13 years ago.Subsequently, the patient was revised approximately 2 weeks ago as the surgeon claims the patient was experiencing metal reaction related issues.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

No product was returned.Visual inspection of the provided pictures identified bio debris and blood on the shell.There were some scratches on the inner diameter on the metal liner.No debris was identified inside the head taper.Medical records/radiographs were provided and reviewed by a health care professional.Very limited information was provided and the review identified armd, adverse reaction of metal debris with pain and weakness.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: M2A-T UNIV 2-HOLE SHL SZ 41/54
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12093072
• MDR Text Key: 259191159
• Report Number: 0001825034-2021-01933
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 15-103684
• Device Lot Number: 056120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 88