MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SIZE 2 130MM STEM LENGTH 12/14; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced elevated metal ion levels approximately 2 years post implantation.However, no revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Report source: source: (b)(6).Concomitant medical products: catalog number: 00801802802, lot number: 63916779, brand name: cocr heads.Catalog number: 00811400200, lot number: 64046654, brand name: cpt stems.Catalog number: ep-200150, lot number: 211640, brand name: act artic e1 hip brg.Catalog number: 010000665, lot number: 6378239, brand name: g7 shell.Catalog number: 110024464, lot number: 857020, brand name: g7 mobility liner.Multiple reports were submitted along with this report: 0002648920-2022-00093, 0001822565-2022-01069.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that the event is not reportable as there was an error in hospital reporting, and the metal levels were not elevated.Additional information received indicated that the hospital lab initially reported the cobalt levels in the unit nmol/l, instead of ug/l.Correct conversions found that the patient did not have elevated cobalt levels.
Event or Problem Description
Upon reassessment of the reported event, it was determined that the event is not reportable as there was an error in hospital reporting, and the metal levels were not elevated.Additional information received indicated that the hospital lab initially reported the cobalt levels in the unit nmol/l, instead of ug/l.Correct conversions found that the patient did not have elevated cobalt levels.

• Brand Name: SIZE 2 130MM STEM LENGTH 12/14
• 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: 14148490
• Report Number: 0002648920-2022-00093
• Device Sequence Number: 14901798
• Product Code: JDI
• UDI-Device Identifier: 00889024145771
• UDI-Public: (01)00889024145771(17)310528(10)64046654
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K960658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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 Model Number: N/A
• Device Catalogue Number: 00811400200
• Device Lot Number: 64046654
• 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: 04/08/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female