MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BAUER LT TRIFLANGE SZ 25; PROSTHESIS, HIP

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Failure to Osseointegrate (1863); Migration (4003)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646)

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient is being scheduled for a left hip revision after an unknown amount of time post implantation due to migration/loosening of a pmi triflange cup.No revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a2; a3; b2; b3; b5; d6b; d9; g3; h2; h6 product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will submitted.

Event Description

It was reported that patient underwent a left hip revision after an unknown amount of time post implantation due to migration and loosening of the cup.Attempts have been made and no additional event information is available at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was returned and evaluated against the reported event.Visual examination identified scuffing on the device and some of the porous coating has been worn off likely from the planting process.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.

Event Description

No additional information on the reported event.

• Brand Name: BAUER LT TRIFLANGE SZ 25
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11739645
• MDR Text Key: 247782053
• Report Number: 0001825034-2021-01274
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00887858391149
• UDI-Public: (01)00887858391149(17)291016(10)263560
• 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,distri
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/18/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PM0002696
• Device Lot Number: 262560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 06/15/2021; 07/26/2021; 09/28/2021
• Supplement Dates FDA Received: 07/01/2021; 07/28/2021; 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention