MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MOD FEMORAL PROX LOCKING SCREW; PROSTHESIS, HIP

Catalog Number	11-301000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: ep-200148- act artic e1 hip brg- 017610, 11-301322-arcos con-474370, 010000663- g7 pps ltd acet shell- 6289244, 110024463- g7 dual mobility liner- 690310, 11-300815- arcos 15x150mm spl tpr- 351720, 00625006535 bone screw 6.5x35 self-tap 63651675, 12-115110- cer bioloxd mod- 2912205, 00223200418- cable cerclage cable- 63989795.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 05335, 0001825034 - 2019 - 05336, 0001825034 - 2019 - 05338, 0001825034 - 2019 - 05339, 0001825034 - 2019 - 05341.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 to hospital.
Event or Problem Description
It was reported that patient underwent right hip revision.Subsequently, patient underwent third revision approximately one and half years post initial implantation for infection.All devices were removed and replaced with cement spacers.Sales rep indicates no additional information is available.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
Event or Problem Description
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: MOD FEMORAL PROX LOCKING SCREW
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9383137
• Report Number: 0001825034-2019-05337
• Device Sequence Number: 2055707
• Product Code: KWA
• UDI-Device Identifier: 00880304490093
• UDI-Public: 00880304490093
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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 Expiration Date: 07/14/2026
• Device Catalogue Number: 11-301000
• Device Lot Number: 810870
• 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: 03/02/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 03/04/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention