MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ A STD 60MM SZ A; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling (2091)
Date of Event	04/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Concomitant medical devices: 11-300813- arcos 13x150mm spl tpr dist- 608040; 00223200205-integral long gtr w/4 cables-56699355; 650-1057-cer bioloxd option hd 36mm- 2018111493; 650-1064-cer option type 1 tpr sleve -6- 2019061522.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 01992.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient underwent a revision surgery approximately 9 months¿ post implantation due to joint swelling.There was no complication during the procedure.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No additional information on reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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: ARCOS CON SZ A STD 60MM SZ A
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10055328
• Report Number: 0001825034-2020-01991
• Device Sequence Number: 2501867
• Product Code: KWA
• UDI-Device Identifier: 00880304468030
• UDI-Public: (01)00880304468030
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2020

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: 11-301301
• Device Lot Number: 307830
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/22/2020
• Supplement Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 07/02/2020
• 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: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention