MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 58ODX52ID; PROSTHESIS, HIP

Model Number N/A

Device Problems Peeled/Delaminated (1454); Naturally Worn (2988)

Patient Problems Pain (1994); Osteolysis (2377); Osteopenia/ Osteoporosis (2651)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).D11: m2a-magnum mod hd sz 52mm, pn 157452, ln 483800, m2a-magnum 52-60mm tpr ins std, pn 139268, ln 650390.Customer has indicated that the product will not be returned to zimmer biomet for investigation due to hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial hip arthroplasty on an unknown date.Subsequently, the patient's cup was revised due to pain and implant wear.Delamination of the coating was found on the cup upon explantation.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.Radiographic inspection identified abnormal radiolucency along both implants consistent with osteolysis, however, there was no evidence of implant loosening.Osteopenia was also identified.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.

Event Description

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

Event Description

It was reported that the patient underwent a revision of right total hip arthroplasty approximately 10 years post initial implantation due to pain.Upon explantation of the cup delamination of the pps coating was discovered.Xray review indicated radiolucency, osteolysis, and osteopenia.All components were revised.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Item#: unknown stem, lot#: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 05645.

• Brand Name: M2A-MAGNUM PF CUP 58ODX52ID
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9453866
• MDR Text Key: 170886970
• Report Number: 0001825034-2019-05350
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: N/A
• Device Catalogue Number: US157858
• Device Lot Number: 768650
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR