MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER AND SHELL WITH PLASTIC BARRIER 44 MM I.D. 56 MM O.D. DO; PROSTHESIS, HIP

Model Number N/A

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog#: 00780402520 hybrid offset shell inserter lot#: 62673127 -catalog#: 00151601056 inserter for use with 56 mm o.D.Cup lot#: 61984892 -catalog#: 00120609056 acetabular reamer shell 56mm lot#: 56656731 -catalog#: 00877704401 bioloxâ® option, head, s, 㸠44/-3.0, taper 12/14 lot#: 3009806 -catalog#: 0100551305 fitmoreâ®, hip stem, uncemented, offset b (extended)/5, taper 12/14 lot#: 3022751.Report source foreign: (b)(6).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.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: 0001822565-2021-00686 0001822565-2021-00687.

Event Description

It was reported that during surgery, the surgeon inserted the cup of the selected size, but after implantation he had problems with disconnecting the inserter and the implant leading to an approximate 50 minute delay in the surgery.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

Upon reassessment of the reported event, the cup was determined to be not reportable as the cup was implanted.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon reassessment of the reported event, the cup was determined to be not reportable as the cup was implanted.The initial report was forwarded in error and should be voided.

• Brand Name: LINER AND SHELL WITH PLASTIC BARRIER 44 MM I.D. 56 MM O.D. DO
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11476303
• MDR Text Key: 244542260
• Report Number: 0001822565-2021-00688
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00889024359512
• UDI-Public: (01)00889024359512(17)301031(10)64724991
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00151505644
• Device Lot Number: 64724991
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2021
• Initial Date FDA Received: 03/12/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1