MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL 46 MM O.D.; PROSTHESIS, HIP

Catalog Number 00500104600

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 12/16/2023

Event Type  Injury  

Event Description

It was reported a patient under when a hip revision approximately two weeks post implantation due to dislocation and loosening from a fall.The patient has a history of dementia, confusion and fall risk.All the components were removed and replaced.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).D10: cat #: 30.00.49.060 / ms-30 size 6 std stem / lot #: 3151804.G2: australia.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: 2 falls and presents with hip dislocation.Pain to right knee, confused.Revision due to dislocation and loosening of stem.The complaint is confirmed based on the evaluation of the provided medical records.Dhr was reviewed and no discrepancies related to the reported event were found.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: SHELL 46 MM O.D.
• Type of Device: 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: 19162366
• MDR Text Key: 340794394
• Report Number: 0002648920-2024-00116
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024115347
• UDI-Public: (01)00889024115347(17)330506(10)65958760
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 00500104600
• Device Lot Number: 65958760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2023
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female