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

Model Number N/A

Device Problems Unstable (1667); Malposition of Device (2616)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Date 10/25/2021

Event Type  Injury  

Event 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 281213958
• Report Number: 0001822565-2021-03372
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024118867
• UDI-Public: (01)00889024118867(17)300726(10)64661920
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K021891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 03/24/2022
• Supplement Dates FDA Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10; SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 78 YR