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

Model Number N/A

Device Problems Material Erosion (1214); Osseointegration Problem (3003)

Patient Problems Pain (1994); Local Reaction (2035); Swelling (2091)

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: taperloc por fmrl lat 13.5x147, pn 11-103207, ln 559800, m2a-magnum mod hd sz 52mm, pn 157452, ln 908320.Multiple mdr reports were filed for this event, please see associated reports 0001825034-2019-03880, 0001825034-2019-03891.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 that a patient underwent right hip arthroplasty.Approximately 9 years later underwent a revision procedure due to aseptic loosening, adverse local tissue reaction, osteolysis, pain, necrosis, swelling, metallosis, and elevated ion levels.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Concomitant medical products : m2a-magnum 52-60mm tpr insr +3, pn 139270, ln 146650.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies 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.

Event Description

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

Manufacturer Narrative

The device was returned and evaluated against the complaint, see the below observations: the inner radius of the cup is scuffed along the side and sporadically scratched.Debris also remains stuck to the porous coating.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.

Event Description

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

• 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: 8963181
• MDR Text Key: 156579163
• Report Number: 0001825034-2019-03879
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: US157858
• Device Lot Number: 921860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2021
• 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