MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH MULTI HOLES 52 MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Malposition of Device (2616)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	10/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent total hip arthroplasty on unknown date.Subsequently underwent revision of implants for instability/aseptic failure.The customer also indicates a 32 cartridge from the company bioball, a polyethylene insert and 4 screws but we can¿t determine where it came from.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant products: unknown stem item/lot unknown.Unknown bone screws item/lot unknown.Report source: (b)(6).The device will not be returned for analysis location unknown; 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:  0001822565 - 2021 - 03370 , 0001822565 - 2021 - 03371.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D6a: implanted on unknown date in 2021 d10: unknown competitors head - unknown part and lot.H6: remove health effect ¿ clinical code 1930 ¿ unspecified infection reported event was unable to be confirmed due to limited information provided by the customer.Device history record was reviewed and no discrepancies were found.It was identified that zimmer biomet devices were implanted with competitor devices.Zimmer biomet has not confirmed the compatibility for these combinations of devices.It is unknown if these off-label usages may have caused or contributed to the reported event.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.
Event or Problem Description
It was reported that patient underwent a hip revision after an unknown amount of time post implantation due to abnormal wear of the poly liner, instability and malpositioning of the devices.The liner, cup and competitors head were removed and replaced.Attempts have been made and the additional information on the reported event is unavailable at this time.

• Brand Name: SHELL POROUS WITH MULTI HOLES 52 MM
• 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: 12870077
• Report Number: 0001822565-2021-03372
• Device Sequence Number: 3485361
• Product Code: LPH
• UDI-Device Identifier: 00889024118867
• UDI-Public: (01)00889024118867(17)300726(10)64661920
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K021891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 04/08/2022

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 Model Number: N/A
• Device Catalogue Number: 00620205220
• Device Lot Number: 64661920
• 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: 11/08/2021
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2020
• 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; SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Unknown