MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 44MM; PROSTHETIC, HIP

Model Number N/A

Device Problems Unstable (1667); Noise, Audible (3273); Patient Device Interaction Problem (4001)

Patient Problems Fall (1848); Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 10/03/2022

Event Type  Injury  

Event Description

It was reported pt underwent a revision procedure 14 years and 9 months post-implantation due to pain, noise, and instability after falling and elevated metal ions.During the revision procedure bursitis was noted, abundant dark joint fluid with black particles, altr and pseudotumor.The stem and cup were well fixed and remained implanted.The head and the adapter were exchanged without complications.There is no additional information available at the time of this report.

Manufacturer Narrative

(b)(4).D4: x12-171311 integral/x por red prox 11mm lot number 791970.139256 m2a-magnum 42-50 tpr insrt std lot number 000920.Us157850 m2a-magnum pf cup 50odx44id lot number 929520.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 01167.0001825034 - 2023 - 01166.0001825034 - 2023 - 01165.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.Device location is unknown.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, d4: expiration date, g3, g6, h2, h3, h6: component code: mechanical (g04) - head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on review of medical records.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: right hip pain after recent fall with back pain and posterior hip pain with popping and instability, mildly elevated metal ions.Well aligned metal-on-metal hip arthroplasty with good ingrowth without sings of loosening.Adverse local tissue reaction lining of the inside of the joint noted with dark tissues and this was completely excised.Thick inflamed bursa noted over the greater trochanter which was scarred and was excised.Upon entering the hip encountered abundant dark joint fluid with black particles.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.

Event Description

There is no update to the prior event description provided.

Event Description

There is no update to the prior event description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h6 component code: mechanical (g04) - head.Visual examination of the returned product identified there are black marks on the face of the insert along with visible indentation.The outer diameter has scuffing.Review of complaint history identified additional similar complaints for the reported item(s) and no additional complaints for the reported part and lot combination(s).Complaints are monitored through monthly complaint review in order to identify potential adverse trends.The additional information does not change the outcome of the previous investigation 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 44MM
• Type of Device: PROSTHETIC, 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: 16983168
• MDR Text Key: 315801768
• Report Number: 0001825034-2023-01168
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2023

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: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 157444
• Device Lot Number: 139410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: 07/19/2023; 10/19/2023
• Supplement Dates FDA Received: 07/21/2023; 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female