MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER STANDARD 3.5 MM OFFSET 36 MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Muscle/Tendon Damage (4532)
Date of Event	06/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial tha was performed.The patient reported stumbling and experienced pain, loosening was not identified.The pain continued and inspection of the hip revealed atrophy, tenderness, pain, and crepitus.The patient received a steroid injection but continues to experience pain.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined, it was noted the patient fell however the reason for the fall is unknown.No problem was found in relation to the bursitis, as it is a procedure related event after review of a hcp.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.Initial report was submitted under the wrong mfr number, see 0001822565-2022-03081.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-03077, 0001822565-2022-03078, 0001822565-2022-03079, 0001822565-2022-03080 and 0001822565-2022-03082.
Event or Problem Description
It was reported that patient experienced left hip atrophy, tenderness, pain and crepitus with range of motion approximately 1.5 years post implantation.The patient received an injection to help with the pain.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: LINER STANDARD 3.5 MM OFFSET 36 MM
• 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: 15958614
• Report Number: 0002648920-2022-00247
• Device Sequence Number: 11999799
• Product Code: LPH
• UDI-Device Identifier: 00889024123762
• UDI-Public: (01)00889024123762(17)250917(10)64778735
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K002960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/17/2025
• Device Model Number: N/A
• Device Catalogue Number: 00630505036
• Device Lot Number: 64778735
• 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: 12/08/2022
• Initial Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2020
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White