MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM I.D. SIZE II ELEVATED RIM LINER; PROSTHESIS, HIP

Catalog Number	00875201032
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	06/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01621.D10: cat #: 51-101080 / tprlc 133 fp type1 pps ho 8.0 / lot #: 3622261.Cat #: 00875705201 / 52mm o.D.Size ii porous uncemented with cluster holes shell use with ii liners / lot #: 65792472.Cat #: 650-1162 / delta cer fem hd 32/0mm t1 / lot #: 3145188.G2: new zealand.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported a patient underwent a hip revision approximately two months¿ post implantation due to instability and an infection.During the procedure, while removing the head and liner, the stem fell out of the patient¿s femur.The head and liner were removed and replaced.Attempts have been made and no further information is available.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The complaint could not be confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined for the dislocation and instability.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is unlikely that the specified device caused any patient infection.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: 32MM I.D. SIZE II ELEVATED RIM LINER
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17342371
• Report Number: 0001822565-2023-01918
• Device Sequence Number: 6912628
• Product Code: JDI
• UDI-Device Identifier: 00889024149717
• UDI-Public: (01)00889024149717(17)280112(10)65780369
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

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 Catalogue Number: 00875201032
• Device Lot Number: 65780369
• 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: 06/23/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female