MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOM XL 44-36 RTNV+3 HMRL BRG; EXTREMITIES, IMPLANT

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	03/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant products: item# 115370, lot# 104300, comp rvs tray co 44mm; item# 118001, lot# 396600, versa-dial/comp ti std taper; item# 115310, lot# 399390, comp rvrs shldr glnsp std 36mm.Foreign: event occurred in (b)(6).The product will not be returned to zimmer biomet for investigation, as the device was discarded.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: 0001825034-2021-00982, 0001825034-2021-00983 and 0001825034-2021-00984.
Event or Problem Description
It was reported that the patient underwent a revision sixteen days after the surgery due to infection.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This would we considered a deep infection that occurred shortly after implantation.No patient comorbidities or risk factors were provided, other than recent revision procedure.Any additional surgical procedures, such as revisions, place the patient at higher risk for post operative complications such as developing an infection.As the reported event of deep 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.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: ARCOM XL 44-36 RTNV+3 HMRL BRG
• Common Device Name: EXTREMITIES, IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11697464
• Report Number: 0001825034-2021-00985
• Device Sequence Number: 11537088
• Product Code: KWS
• UDI-Device Identifier: 00880304475519
• UDI-Public: (01)00880304475519(17)240919(10)689180
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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 Expiration Date: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: XL-115365
• Device Lot Number: 689180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/27/2021
• 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