MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 42MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Osteolysis (2377); Metal Related Pathology (4530)

Event Date 07/21/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent total hip arthroplasty.Subsequently, the patient was revised approximately twelve (12) years later due to metal-on-metal.During the revision, discolored synovial tissue, mostly related to metal-on-metal adverse tissue reaction, was observed.Osteolysis was observed towards the ischium and pubic bone.The initial stem was retained, all other components were revised without complication.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Concomitant medical products: biomet ref.(b)(4), lot#: 906730, m2a magnum taper adapter; biomet ref.(b)(4), lot#: 044190, echo bi-metric collarless porous stem.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02873.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.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.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 additional event information to report at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

(b)(4).Proposed component code: mechanical (g04) - head this follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3; h2; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies related to the reported event 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.

• Brand Name: M2A-MAGNUM MOD HD SZ 42MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16077393
• MDR Text Key: 306417642
• Report Number: 0001825034-2022-02874
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2023

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: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 157442
• Device Lot Number: 789080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 01/04/2023; 01/10/2023
• Supplement Dates FDA Received: 01/10/2023; 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female