MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER 28 MM I.D. FOR USE WITH 44/45/46 MM O.D. SHELLS; PROSTHESIS, HIP

Catalog Number	00500104428
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right hip revision approximately 12 days post implantation due to a dislocation and loosening of the stem from falling.All components were removed and replaced.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00104, 0009613350-2023-00716.D10: cat#: 802202802 / zb 12/14 cocr hd 28mm x +0/ lot#: 3173761.Cat#: 30.00.49.060 / ms-30 size 6 std stem / lot#: 3151804.G2: australia.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).Upon receiving additional information of the reported event, it was determined to be not reportable as this product did not cause or contribute to the event.The initial report should be voided.
Event or Problem Description
Upon receiving additional information of the reported event, it was determined to be not reportable as this product did not cause or contribute to the event.The initial report should be voided.

• Brand Name: LINER 28 MM I.D. FOR USE WITH 44/45/46 MM O.D. SHELLS
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18477569
• Report Number: 0002648920-2024-00009
• Device Sequence Number: 15184331
• Product Code: KWY
• UDI-Device Identifier: 00889024633254
• UDI-Public: (01)00889024633254(17)280125(10)66812788
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K833991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/02/2024

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 Catalogue Number: 00500104428
• Device Lot Number: 65812788
• 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: 12/16/2023
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Female