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

Catalog Number	00801802801
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Post Operative Wound Infection (2446)
Date of Event	12/22/2020
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 product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: part # 110024462 / liner/ lot # 812450; part #010000996/ g7 screw/ lot # 6596542; part #0106010103/ avenirâ® mã¼ller, stem/ lot # 2854319; part # 010000998/ screw/ lot #6833035; part #010000999/ screw/ lot # 637769; part # ep-200146/ acitve articulation insert/ lot# 964730.Report source: (b)(6).The event was previously reported on 0001825034 -2021 -00069 from (b)(4).
Event or Problem Description
It was reported that during patient was revised one-month post implantation due infection.The surgeon did a wound debridement and exchanged the head and liner.Attempts have been made and additional information on the reported event is unavailable at this time.
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.The following sections were updated/corrected.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet product.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: COCR FEMORAL HEAD
• Common Device Name: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11275453
• Report Number: 0001822565-2021-00310
• Device Sequence Number: 14343246
• Product Code: LPH
• UDI-Device Identifier: 00889024144613
• UDI-Public: (01)00889024144613(7)291031(10)64521813
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2021

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 00801802801
• Device Lot Number: 64521813
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention