MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEAD STERILE PRODUCT; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Corroded (1131); Degraded (1153)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	02/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised due to pain and elevated cobalt levels approximately 8 years post implantation.During the revision, fluid was obtained consistent with trunnionosis.It was also noted that the capsule was very thick consistent with taper corrosion.A new femoral head and liner were placed without complication.Additional information on the reported event is unavailable.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog number: 536000059 lot number:62192810 brand name: acetabular shell, catalog number:437732059 lot number:62098547 brand name: durasulâ¿¢ hooded insert, catalog number:00801803203 lot number:61542839 brand name: cocr heads, catalog number:00786201630 lot number:07886625 brand name: versys stem.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.
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number: (b)(4).
Event or Problem Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number: (b)(4).

• Brand Name: FEMORAL HEAD STERILE PRODUCT
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14498009
• Report Number: 0001822565-2022-01571
• Device Sequence Number: 14867533
• Product Code: LPH
• UDI-Device Identifier: 00889024144682
• UDI-Public: (01)00889024144682(10)61542839
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• 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,Followup
• Report Date (Section B): 08/30/2022

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: 00801803203
• Device Lot Number: 61542839
• 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: 05/03/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 08/31/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 149 KG