MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT 12/14 TAPER; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Corroded (1131); Material Erosion (1214)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Fibrosis (3167); Metal Related Pathology (4530)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part: 00771100910, lot: 61416336, femoral stem 12/14 neck taper press-fit cementless size 9 standard offset reduced neck length.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-02968.
Event or Problem Description
It was reported the patient underwent initial right total hip arthroplasty and subsequently, the patient was revised 9 years later due to pain and elevated metal ions.During the revision, necrotic tissue was debrided.Corrosion was cleaned from the trunnion.Only the femoral head was exchanged.No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed due to the review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed.A lab done shows elevated cobalt levels.A revision was performed due to increased pain and elevated cobalt levels.Corrosion was noted on the trunnion and a necrotic capsule was removed.Only the head was replaced, as the liner was in good condition.Zimmer biomet product was implanted.Device history record (dhr) was reviewed and no discrepancies were found.A definitive 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.

• Brand Name: FEMORAL HEAD STERILE PRODUCT 12/14 TAPER
• 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: 12629103
• Report Number: 0002648920-2021-00342
• Device Sequence Number: 19688515
• Product Code: LZO
• UDI-Device Identifier: 00889024144675
• UDI-Public: (01)00889024144675(17)200530(10)61530648
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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: 05/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 00801803202
• Device Lot Number: 61530648
• 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: 09/17/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female
• Patient Weight: 60 KG