MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEUTRAL POLY LINER 36MM SET; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip procedure, the liner broke during impaction.There was no reported harm or injury to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D10: 00620205422 - tm modular cup ¿ 64553146; 00625006525 ¿ bone screw ¿ j7378276; 00771301500 ¿ m/l taper stem ¿ 64960515; 00784802300 ¿ kinectiv neck ¿ 65595695; 00877503602 ¿ biolox head ¿ 3133374.Visual examination of the returned product/provided pictures identified nicks, gouges, scratches, deformation, and rim fracture.Polar boss is deformed from attempted implant.Outer spherical surface shows gouges.Fracture is noted near the anti rotation scallops and the lock ring groove.Gouge damage is noted on the damaged rim.No other damage was noted.The liner was sent to fracture analysis.Results: the liner was not centered or aligned with the cup when it was impacted, and the misalignment during impaction resulted in the fracture.Review of the device history records identified no deviations or anomalies during manufacturing.A root cause for this event cannot be determined.Event was previously reported under a different mfr number, see 0001822565-2023- 00339.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: NEUTRAL POLY LINER 36MM SET
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16794948
• Report Number: 0002648920-2023-00080
• Device Sequence Number: 6377693
• Product Code: JWH
• UDI-Device Identifier: 00889024123762
• UDI-Public: (01)00889024123762(17)260505(10)64970887
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K972774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2023

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 Expiration Date: 05/05/2026
• Device Model Number: N/A
• Device Catalogue Number: 00630505036
• Device Lot Number: 64970887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• 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: 04/20/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2021
• 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
• Patient Sex: Unknown