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

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	05/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item# 010000589; comp rvrs 25mm bsplt ha+adptr; lot# 296770, item# 115395; comp rvs cntrl 6.5x25mm st/rst; lot# 522910, item# 115313; comp rvsr shldr glnsp +3 36mm; lot# 020060, item# 180553; comp lk scr 3.5hex 4.75x30 st; lot# 602720, item# 180553; comp lk scr 3.5hex 4.75x30 st; lot# 042760, item# 180554; comp lk scr 3.5hex 4.75x35 st; lot# 878350, item# 113613; comp primary stem 13mm micro; lot# 904750, item# 115378; comp rvs tray +10mm co 44mm; lot# 800040.Report source: (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-02449, 0001825034-2019-04938, 0001825034-2019-04940, 0001825034-2019-04941, 0001825034-2019-04942, 0001825034-2019-04943, 0001825034-2019-04944.0001825034-2019-04945.
Event or Problem Description
It was reported that the patient underwent a revision procedure approximately eight months post initial due to infection.A spacer mold was temporarily implanted and removed at a later date.No further information is available.

• Brand Name: ARCOM XL 44-36 STD +3 HMRL BRG
• Common Device Name: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9317032
• Report Number: 0001825034-2019-04946
• Device Sequence Number: 13568011
• Product Code: KWS
• UDI-Device Identifier: 00880304475434
• UDI-Public: (01)00880304475434
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K080642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2019

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: 07/31/2017
• Device Model Number: N/A
• Device Catalogue Number: XL-115364
• Device Lot Number: 247330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 11/13/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention