MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 52ODX46ID; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) concomitant medical devices: ep-200152 ¿ e1 active articulation bearing ¿ 530950; 650-1159 ¿ delta ceramic head ¿ 2019102612; 192413 ¿ echo stem ¿ 925640.Report source (b)(6).Customer has indicated that the product will not be returned to zimmer biome for the investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04328.
Event or Problem Description
It was reported that patient a hip revision approximately 1 month post implantation and a second revision approximately 1 month after that due to dislocation and dissociation of the head and bearing.It was reported that the patient experienced a fall.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Medical records were reviewed by a third party hcp and noted superior left hip dislocation of the left hip total arthroplasty which may have been the result of a possible oversized cup.Dhr was reviewed and no discrepancies were found.A definitive root cause cannot be determined.The patient was putting on socks that could have contributed to the dislocation of the bearing from the cup and therefore this device is considered to be not reportable.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 PF CUP 52ODX46ID
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10984094
• Report Number: 0001825034-2020-04330
• Device Sequence Number: 4295703
• Product Code: LPH
• UDI-Device Identifier: 00880304993501
• UDI-Public: (01)00880304993501
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: US157852
• Device Lot Number: 708550
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR