MAUDE Adverse Event Report: ZIMMER GMBH FITMORE®, HIP STEM, UNCEMENTED, B/7, TAPER 12/14; HIP IMPLANT

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Ambulation Difficulties (2544)

Event Date 07/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6) g2: foreign: germany d10: 32mm i.D.Size hh neutral liner use with 50mm o.D.Size hh shell item # 00875100932 lot #61616435 bioloxâ® forte, head, s, 㸠32/-4, taper 12/14 item # 123205 lot #2616162 allofitâ® it alloclassicâ®, shell for acetabulum, uncemented, 50/hh item #00875505000 lot # 2611175 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.

Event Description

It was reported by clinical that a patient underwent an initial right total hip arthroplasty on (b)(6) 2011.Subsequently, on (b)(6) 2020, the patient underwent a revision of the femoral head and stem due to a traumatic fracture of the femoral shaft.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint histories found no additional related complaints for this item and the reported part and lot combination.With the available information, a definitive root cause could not 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 Description

No additional information at this time.

• Brand Name: FITMORE®, HIP STEM, UNCEMENTED, B/7, TAPER 12/14
• Type of Device: HIP IMPLANT
• 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: 18379219
• MDR Text Key: 331175895
• Report Number: 0009613350-2023-00707
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024393745
• UDI-Public: (01)00889024393745(17)210731(10)2612021
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K192236
• 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,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 0100551207
• Device Lot Number: 2612021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 86 KG