MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 32MM +3 MAXROM LNR SZ22; PROSTHESIS HIP

Catalog Number	EP-108222
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant products: part # 51-104100 / tprlc 133 t1 pps ho / lot # u 3647654; part # 103533 / ti low profile screw/ lot # 444390; part # 123741 / 3/8-24 apical hole / lot # 44180 ; part # 16-116048 rnglc+ ltd hole shell / lot # 374690; part # 650-1056 / cer bioloxd option hd lot # 319030; part # 650-1067/ tpr sleve +3 pe 1lot # 330150.
Event or Problem Description
It was reported that patient underwent bilateral hip replacement surgery approximately 5 years ago.Patient began experiencing pain and grinding.Radiographs show what appears to be a catastrophic failure of the liner.Patient reported no trauma or injury.No revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, g3, h2, h3, h6.Reported event was confirmed by review of radiographs.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.Radiographs identified the following: overall sizing of the right total hip arthroplasty is appropriate.Femoral component is incompletely evaluated.Asymmetric positioning of the femoral head within the right acetabular cup, consistent with polyethylene wear.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: E-POLY 32MM +3 MAXROM LNR SZ22
• Common Device Name: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12777862
• Report Number: 0001825034-2021-03065
• Device Sequence Number: 17009169
• Product Code: MAY
• UDI-Device Identifier: 00880304469082
• UDI-Public: (01)00880304469082(17)220402(10)274330
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K090103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

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 Expiration Date: 04/02/2022
• Device Catalogue Number: EP-108222
• Device Lot Number: 274330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female