MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 42-50MM TPR INSRT-3; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Host-Tissue Reaction (1297)

Event Date 04/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: biomet m2a-magnum mod hd sz 44mm cat#157444 lot#426050; biomet m2a-magnum 42-50mm tpr insrt-3 cat#139254 lot#945180; biomet taperloc por lat fmrl 11x142 cat#11-103205 lot#691810; biomet m2a-magnum pf cup 50odx44id cat#us157850 lot#480120.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: partial tear of gluteus medius tendon secondary to pseudotumor or degenerative in nature.About 60% tear of the tendon from the greater trochanter.There was no real tissue destruction.There was some cloudy fluid and some mild synovial hypertrophy.Cultures sent (no report).Sed rate was 2.C-reactive protein was negative suggesting no infection.Cobalt was 1.1 which is below threshold.Mri indicated fluid around the trochanter.Mri showed increased fluid communicating with the joint suggesting a tear of the gluteus medius tendon.This caused concern about the possibility of a pseudotumor.The remainder of the tissue looked beefy-red consistent with healthy tissue.The tear was able to be repaired.No intra-operative complications identified.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04362.

Event Description

It was reported that the patient had an initial right total hip arthroplasty.Subsequently, the patient was revised approximately 10 years later due to tendon tear and pseudotumor.The head and taper adapter were removed and replaced with a dual mobility bearing and delta femoral head.No further event information available at the time of this report.

• Brand Name: M2A-MAGNUM 42-50MM TPR INSRT-3
• 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: 11012142
• MDR Text Key: 221546260
• Report Number: 0001825034-2020-04363
• 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
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 139254
• Device Lot Number: 945180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2008
• 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): Hospitalization; Required Intervention