MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 54 MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Liner standard 3.5 mm offset 36 mm cat# 00630505036 lot# 64443428, bone screw self-tapping 6.5 mm cat# 00625006525 lot# 64504218, bone screw self-tapping 6.5 mm cat# 00625006525 lot# 64504218, avenirâ® mã¼ller, stem cat# 0106010103 lot# 2947243, bioloxâ® delta, ceramic femoral head cat# 00877503601 lot# 2993744.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02961, 0001822565-2020-02962, 0001822565-2020-02963.
Event or Problem Description
It was reported the patient underwent a hip revision approximately 1 year post implantation due to a periprosthetic infection.No additional information.
Additional Manufacturer Narrative
(b)(4).Upon receipt of additional information, it has been determined that the reported event was determined to be unrelated to the implanted zimmer biomet device.The initial report was forwarded in error and should be voided.The reported event of infection >90 days occurred post implantation.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.
Event or Problem Description
Upon receipt of additional information, it has been determined that the reported event was determined to be unrelated to the implanted zimmer biomet device.The initial report was forwarded in error and should be voided.

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 54 MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10416059
• Report Number: 0001822565-2020-02960
• Device Sequence Number: 14123775
• Product Code: LPH
• UDI-Device Identifier: 00889024118911
• UDI-Public: (01)00889024118911(17)280731(10)64005417
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K021891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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 Model Number: N/A
• Device Catalogue Number: 00620205422
• Device Lot Number: 64005417
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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 Weight: 50