MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 48MM O.D. POROUS UNCEMENTED W CLUSTER HOLES SHELL; PROSTHESIS, HIP

Catalog Number	00875304801
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00939, 0001822565-2023-00940, 0001822565-2023-00941.D10: cat #: 00875304801/lot #: 65468500/48mm o.D.Size gg porous uncemented with cluster holes shell use with gg liners.Cat #: 00875200832/lot #: 65587506/32mm i.D.Size gg elevated rim liner use with 48mm o.D.Size gg shell.Cat #: 00875200832/lot #: 65574345/32mm i.D.Size gg elevated rim liner use with 48mm o.D.Size gg shell.G2: india.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a procedure, the liner would not assemble with the cup.Another liner and cup of the same size were used, but also would not assemble correctly.The surgeon then, reamed the bone a second time with one size greater than anticipated and these devices were able to function properly and were implanted.It was reported that no further information is available at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified that the liners were assembled to the shells as intended.The liners showed anti rotation scallops and elevated rim flush with the shell as intended when assembled.Liners exhibit damage to the elevated rim.Liner inner spherical surfaces show indentations and scratches from attempted use.Shell rims show scratches.No other damage was noted.No problem was found with the returned devices.This complaint cannot be confirmed.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
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.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause was unable to 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
No additional event information to report at this time.

• Brand Name: 48MM O.D. POROUS UNCEMENTED W CLUSTER HOLES SHELL
• 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: 16689396
• Report Number: 0001822565-2023-00938
• Device Sequence Number: 5930602
• Product Code: JDI
• UDI-Device Identifier: 00889024150133
• UDI-Public: (01)00889024150133(17)321125(10)65714412
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00875304801
• Device Lot Number: 65714412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/15/2023
• Supplement Date Received by Manufacturer: 05/03/2023; 08/31/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/04/2023; 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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
• Patient Age: 47 YR
• Patient Sex: Male