MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 52-60MM TPR INSRT-3; PROSTHETIC, HIP

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Host-Tissue Reaction (1297); Ossification (1428); Bacterial Infection (1735); Cyst(s) (1800); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Sepsis (2067); Osteolysis (2377); Reaction (2414)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unk cup, pn unknown, ln unknown, unk head, pn unknown, ln unknown, unk stem, pn unknown, ln unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05778, 0001825034-2019-05779, 0001825034-2019-05781.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by patients¿ legal counsel that the patient underwent a left hip revision procedure approximately 11 years post-implantation due to metallosis, infection and sepsis, necrosis and tissue damage.Attempts were made to obtain additional information; however, none was available.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.All devices manufactured follow acceptable sterilization processes according to published iso/aami/astm & eu guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As all product manufactured follow appropriate standards, and the reported infection occurred 90 days, devices can be excluded as a possible source.A review of the device history records identified no deviations or anomalies during manufacturing for the taper.Medical records/radiographs were provided and reviewed by a health care professional.A definitive root cause cannot be determined.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level or better.Therefore, it is unlikely that the specified device caused any patient infection.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 52-60MM TPR INSRT-3
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9526877
• MDR Text Key: 174259686
• Report Number: 0001825034-2019-05780
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2021

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: 09/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 139256
• Device Lot Number: 347200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 05/11/2021; 06/03/2021
• Supplement Dates FDA Received: 06/01/2021; 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention