MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL STEM 12/14 NECK TAPER EXTRA; PROSTHESIS HIP

Catalog Number	00811400330
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hypovolemia (2243)
Date of Event	08/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: (b)(6).Concomitant medical products: item # ep-200150 / act artic e1 hip brg/lot # 483770.Item # 00877502802 /bioloxâ® delta head / lot # 3068663.
Event or Problem Description
It was reported a patient underwent a right hip revision surgery 2 months¿ post implantation due to periprosthetic fracture.Head, bearing and, stem were revised.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed a revision occurred due to a periprosthetic fracture, where the previous anterior approach was utilized.Cables reduced the fracture.The stem, head, bearing, and cement were removed and replaced with zimmer components.Device history record (dhr) was reviewed and no discrepancies 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
It was reported that patient underwent a right hip revision surgery 2 months post implantation due to periprosthetic fracture.The head, bearing, and stem were exchanged and cerciage cables placed without difficulty.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER EXTRA
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12421705
• Report Number: 0002648920-2021-00246
• Device Sequence Number: 16989978
• Product Code: JDI
• UDI-Device Identifier: 00889024145849
• UDI-Public: (01)00889024145849(17)300531(10)64631448
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2021

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 00811400330
• Device Lot Number: 64631448
• 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: 08/13/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2020
• 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 Sex: Male
• Patient Weight: 120 KG