MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 54ODX48ID; PROSTHESIS, HIP

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Scar Tissue (2060); Metal Related Pathology (4530)

Event Date 11/27/2019

Event Type  Injury  

Event Description

It was reported the patient underwent a left hip revision approximately 10 years post implantation due to altr.During the revision scar tissue and adhesions were noted.The head was exchanged without complications.The stem and cup remained implanted.No additional information.

Manufacturer Narrative

(b)(4).Concomitant products: cat#157448 m2a-magnum mod hd sz 48mm lot# 053360; cat# x180309 bi-metric/x por nc 9x125 lot# 416780; cat# 139259 m2a magnum 42-50m lot# 330050.The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned femoral head identified the taper of the device had damage.The outside radius of the device has a wear mark along with scuffing to the polish.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: posterolateral incision with scar tissue and adhesions.Abductors perfectly healed.In joint adverse local tissue was noted, specimen sent and negative for acute inflammation.Doctor was able to dissociate the cold-welded large metal head from trunnion without damaging the trunnion.Trunnion cleaned and dried.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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-MAGNUM PF CUP 54ODX48ID
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13667039
• MDR Text Key: 286582451
• Report Number: 0001825034-2022-00473
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: N/A
• Device Catalogue Number: US157854
• Device Lot Number: 868680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 03/04/2022
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female