MAUDE Adverse Event Report: ZIMMER GMBH DELTA CER FEM HD 28/-3MM T1; HIP PROSTHESIS

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	07/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: australia.D10: associated products: item reference:ep-200152, item name:act artic e1 hip brg 28x46mm, item lot:272470.Item reference:51-110080, item name:tprlc 133 fp type1 bm so 8.0, item lot:3925828.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 3500a will be submitted.
Event or Problem Description
It was reported that patient underwent revision of hip prosthesis due to implant subsidence, which led to instability and dislocation.Revision took place approximately four (4) months after initial surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the provided picture identified the liner component, however it doesn't show the head therefore no evaluation of visual condition can be made of the head component within this complaint.A review of the device manufacturing records confirmed no abnormalities or deviations device is used for treatment.Radiographs were provided and reviewed by a radiologist who reported that the femoral implant appears inferiorly positioned consistent with the reported subsidence but there are no earlier images for comparison.The entire pelvis is not imaged so an abduction angle cannot be measured but the acetabular cup appears somewhat vertical in position.There is no current dislocation.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: DELTA CER FEM HD 28/-3MM T1
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 17413293
• Report Number: 0009613350-2023-00422
• Device Sequence Number: 8902475
• Product Code: LZO
• UDI-Device Identifier: 00887868271533
• UDI-Public: (01)00887868271533(17)261125(10)2016111374
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 10/18/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 650-1159
• Device Lot Number: 2016111374
• 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: 07/04/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 53 KG