MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LONGEVITY DM BEARING 28X44MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); Muscle/Tendon Damage (4532)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient received a revision total hip arthroplasty approximately six (6) months after initial surgery due to the 28mm ceramic head dislocating from the dual mobility bearing.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: cat# 650-1055, lot# 6020426 cer bioloxd option hd 28mm.Cat# 650-1068, lot# a521021289 cer option type 1 tpr sleve +6.Cat# 110024464, lot# 725530 g7 dual mobility liner 44mm f.The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Visual examination of the returned product identified wear damage to the inner and outer spherical surfaces from use.Damage includes nicks, indentations, and scratches.No other damage was noted.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed.There was a subsequent revision with a head and liner exchange due to dislocation and a tendon tear.A second revision occurred due to dislocation, disassociation, and retear of the tendon.It was noted that the head was located within the joint but the dm bearing was just posterior and superior to the acetabulum.A new head and liner were placed, with the tendon repaired.No complications noted.A definitive root cause cannot 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: LONGEVITY DM BEARING 28X44MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16643361
• Report Number: 0001822565-2023-00884
• Device Sequence Number: 5367716
• Product Code: LPH
• UDI-Device Identifier: 00889024572584
• UDI-Public: (01)00889024572584(17)270620(10)65509335
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K190656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2023

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 Model Number: N/A
• Device Catalogue Number: 110031000
• Device Lot Number: 65509335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female