MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROSTHESIS, HIP

Catalog Number	00801802803
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3006946279-2023-00048, 0001822565-2023-01763.D10: cat #: p0463046 / avantage cemented cup s46 / lot #: 0001655736.G2: austria.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient was implanted with unknown products on an unknown date.Approximately 16 years post implantation, the patient experienced a revision for a periprosthetic acetabular fracture with loosening of the cup.The stem was retained, the acetabular components were revised without complication along with a plate and screws to stabilize the fracture.Then it was later reported a patient underwent a right hip revision approximately three months¿ post implantation due to loosening of the cup and disassociation of the head and mobility components.A smaller cup was cemented into place with a head and liner.The initial stem remained implanted.Attempts have been made and no further information is available.
Event or Problem Description
No additional event information to report at this time.
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 corrected: h4 proposed component code: mechanical (g04) ¿head 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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: 1.Right total hip arthroplasty with fractured medial wall of the acetabulum and associated cement in this region.Follow-up image demonstrates protrusion of the acetabular cup medially along with loosening of the cup and rotation.There is evidence of polyethylene liner wear or fracture causing asymmetric positioning of the femoral head within the acetabular cup.2.Possible incomplete evaluation of a right superior pubic ramus fracture on the prior to revision image.This complaint is confirmed based on the provided medical records.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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified head spherical surface shows wear from use.Taper hole shows no damage.Rim has gouges.No other damage was noted.Root cause remains unchanged.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: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• 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: 17252657
• Report Number: 0002648920-2023-00141
• Device Sequence Number: 20543061
• Product Code: LPH
• UDI-Device Identifier: 00889024144637
• UDI-Public: (01)00889024144637(17)320905(10)65610444
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K953337
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2024

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: 00801802803
• Device Lot Number: 65610444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/20/2023
• Supplement Date Received by Manufacturer: 08/15/2023; 02/29/2024
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 08/23/2023; 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female