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

Catalog Number	11-301302
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 11-301302-arcos con-005320, 11-300815- arcos 15x150mm spl-351720, 12-115110- cer bioloxd mod- 2932151, 00223200205- integral long cables- 56670992, 010000663- g7 pps ltd acet shell- 6289244, 00625006535- bone scr self-tap- 63651675, 110024463- g7 dual mobility liner- 690310, ep-200148- act artic e1 hip brg- 90713.Multiple mdr reports were filed for this event, please see associated reports: customer has indicated that the product will not be returned to zimmer biomet for investigation, requested but not returned by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Requested but not returned by hospital.
Event or Problem Description
It was reported that patient underwent right total hip arthroplasty.Subsequently, the proximal body spun and patient was revised to remove the 60mm proximal body and replace with a 70mm.Sale rep indicates no additional information is available.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
Reported event is unable to be confirmed due to limited information provided by the customer.Dhr was reviewed and no discrepancies were found.The root cause is 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 -05327.

• Brand Name: ARCOS CON SZ B STD 60MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9368973
• Report Number: 0001825034-2019-05326
• Device Sequence Number: 11318985
• Product Code: KWA
• UDI-Device Identifier: 00880304474123
• UDI-Public: 00880304474123
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 11-301302
• Device Lot Number: 005320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 03/31/2020
• 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