MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 PPS SO 8.0; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/12/2018

Event Type  Injury  

Event Description

It was reported during an initial left hip hemiarthroplasty, the patient experienced a trochanter fracture.No further treatment or intervention was provided.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Foreign: (b)(6).Concomitant medical products: 163662- 28mm mod hd std neck tp1 taper-unknown, 110010465- e1 ringloc bipolar 28x46mm-unknown.Nakamura, t., yamakawa, t., hori, j., goto, h., nakagawa, a., takatsu, t., osamura, n., saito, a., hagio, k., mouri, k.(2021) conjoined tendon preserving posterior approach in hemiarthroplasty for femoral neck fractures: a prospective multicenter clinical study of 322 patients.Journal of orthopaedic surgery 29(3) 1¿8.Https://doi.Org/10.1177/23094990211063963.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6 component code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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.

Event Description

No additional information on the reported event.

• Brand Name: TPRLC 133 FP TYPE1 PPS SO 8.0
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14270395
• MDR Text Key: 290686591
• Report Number: 0001825034-2022-00998
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00880304489660
• UDI-Public: (01)00880304489660(17)270805(10)6100314
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-100080
• Device Lot Number: 6100314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 41 KG