MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog number: 0100551404, lot number: 2534526, brand name: fitmoreâ®, hip stem; catalog number: 00875201336, lot number: 62969947, brand name: liner elevated rim 36 mm; catalog number: 00875705801, lot number: 62939377, brand name: acetabular shell; catalog number: 00625006535, lot number: 62955422, brand name: bone screw.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.Device remains implanted in the patient.
Event or Problem Description
It was reported that the patient experienced elevated metal ion levels approximately 6 years post implantation.Patient also had aspiration due to fluid.Patient is going to have a culture and cell count.He has had multiple magnetic resonance imagining (mris) that show he may possibly have a pseudotumor.No revision procedure has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Reported event was unable to be confirmed.A review of the device history records identified no deviations or anomalies during manufacturing.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMORAL HEAD STERILE PRODUCT
• 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: 12187960
• Report Number: 0002648920-2021-00188
• Device Sequence Number: 16514023
• Product Code: LPH
• UDI-Device Identifier: 00889024144743
• UDI-Public: (01)00889024144743(17)310824806789
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2021

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: 08/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00801803604
• Device Lot Number: 62806789
• 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: 06/23/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2014
• 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: Hospitalization; Required Intervention
• Patient Sex: Male