MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. 36MM I.D. SIZE KK NEUTRAL LINER USE WITH 56MM O.D. SIZE KK SHELL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	10/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00875705601 ¿ shell ¿ 63208234.00625006530 ¿ bone screw - 63213977.Medical records were provided and reviewed by a health care professional.Review of records identified that the patient had lab testing done that showed elevated cobalt levels.A revision surgery was preformed where altr was found within the joint.Corrosion was found on the trunnion and osteolysis around the stem.The stem and shell were well fixed.The head and liner were replaced without complications.Lab tests were conducted after the revision showing a decrease in metal ion levels.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause is 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.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2022-00080, 0001822565-2021-02807.Previously reported under 0001822565-2022-00982.
Event or Problem Description
It was reported that patient developed elevated metal ions and underwent a left hip revision approximately 3 years post implantation.During the procedure, altr, trunnion corrosion and liner wear were found.The stem and cup remained well fixed.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: 36MM I.D. SIZE KK NEUTRAL LINER USE WITH 56MM O.D. SIZE KK SHELL
• 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: 14410017
• Report Number: 0002648920-2022-00122
• Device Sequence Number: 20218523
• Product Code: JDI
• UDI-Device Identifier: 00889024149199
• UDI-Public: (01)00889024149199(17)201031(10)63203851
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• 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): 05/16/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00875101236
• Device Lot Number: 63203851
• 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: 05/12/2022
• Initial Report FDA Received Date: 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2015
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 91 KG