MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER 10 DEGREE ELEVATED RIM 32 MM; PROSTHESIS, HIP

Catalog Number	00631005032
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a revision due to a dislocation.The liner and head were replaced.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).Report source: australlia.Concomitant medical products: cat #: 00877503202/ biolox⮠delta, ceramic femoral head, m, 㸠32/0, taper 12/14/ lot #: 2923921.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4, b5, g3; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause was 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.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: LINER 10 DEGREE ELEVATED RIM 32 MM
• 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: 16582379
• Report Number: 0001822565-2023-00774
• Device Sequence Number: 11158882
• Product Code: LPH
• UDI-Device Identifier: 00889024499058
• UDI-Public: (01)00889024499058(17)291031(10)3014471
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K990135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2023

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 Expiration Date: 09/30/2023
• Device Catalogue Number: 00631005032
• Device Lot Number: 64147166
• Was Device Available for Evaluation?: No
• 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: 02/28/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female