MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER NEUTRAL 36 MM I.D; 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); Ambulation or Postural Difficulties (2544)
Date of Event	07/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced severe pain from the hip, a severe limp, and difficulty with ambulation approximately 7 years post implantation.However, no revision has been reported to date and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: part 00875505202 lot 2737388 acetabular cup; part 00875505000 lot 2756567 bone screw; part 00877503603 lot 2735781 femoral head; part 0106010004 lot 4020629 femoral stem.Medical records were not provided.Crf data provided states that patient had office visits 6 months, 1 year,2 year, 3 year, 5 year and 7 year post op stated that patient was experiencing pain and difficulty ambulating and do performing daily activities.X-rays did not indicate any issues.At about 7 year follow up patient was experiencing severe pain and severe limping.Reported event was unable to be confirmed.Review of device history records identified no deviations or anomalies during manufacturing.Root cause could not 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.Device remains implanted in the patient.

• Brand Name: LINER NEUTRAL 36 MM I.D
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13193902
• Report Number: 0002648920-2022-00006
• Device Sequence Number: 20351396
• Product Code: JDI
• UDI-Device Identifier: 00889024149137
• UDI-Public: (01)00889024149137(17)311018(10)62519895
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K151448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2022

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: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00875101036
• Device Lot Number: 62519895
• 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: 01/05/2022
• Initial Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2013
• 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
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 112 KG