MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 50MM; PROSTHETIC, HIP

Model Number N/A

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

Patient Problems Pain (1994); Reaction (2414); Metal Related Pathology (4530)

Event Date 12/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: item number us157856 item name m2a-magnum pf cup 56odx50id lot # 815320; item number 11-103204 item name taperloc por fmrl lat 10x140 lot # 906780.The device will not be returned for analysis due to hospital policy; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00077.

Event Description

It was reported that patient underwent right total hip arthroplasty.Subsequently, patient was revised 12 years later due to pain.Metallosis was found during the revision but not enough to take the stem.The head and taper adapter were removed and replaced with active articulation devices.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

  d10: item number 11-103204 item name taperloc por fmrl lat 10x140 lot # 906780 item number 139254 item name m2a-magnum 42-50mm tprinsrt-3 lot # 312640 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event.Medical records were not provided.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: 0001825034-2021-01275.

• Brand Name: M2A-MAGNUM MOD HD SZ 50MM
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11170727
• MDR Text Key: 226815973
• Report Number: 0001825034-2021-00078
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

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: 10/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 157450
• Device Lot Number: 233960
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention