MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Codes	Material Erosion (1214); Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure 6 years and 9 months post implantation due to the liner fracturing at the locking ring.There was metal transfer onto the ceramic femoral head and evidence that the head had been rubbing on the interior of the acetabular shell.Ambulation was limited by pain.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10:00620005022 item name shell porous with cluster holes 50 mm o.D.Lot # 63283875 00877503602 item name bioloxâ® delta, ceramic femoral head, m, 㸠36/0, taper 12/14 lot # 2844194 multiple mdr reports were filed for this event, please see associated reports 0002648920 - 2023 - 00311 0009613350-2023-00696 the device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text : device location is unknown.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
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.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event medical records were not provided.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.

• Brand Name: LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS
• Common Device Name: PROSTHETIC, 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: 18345750
• Report Number: 0001822565-2023-03621
• Device Sequence Number: 17697634
• Product Code: LPH
• UDI-Device Identifier: 00889024123762
• UDI-Public: (01)00889024123762(17)210531(10)63353645
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K002960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2024

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: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00630505036
• Device Lot Number: 63353645
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2023
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2016
• 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: Unknown
• 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: PLEASE SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 72 KG