MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Journal article source: 1.Hemmila et al., 2021: results section, page number 319 ¿ revision due to liner breakage was reported (https://doi.Org/10.1080/17453674.2021.1879513) (b)(6) no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021-03451, 0001825034 - 2021-03452m, 0001825034-2021 03453.

Event Description

It was reported on 14-dec-2021, a journal article was retrieved from acta orthopaedica (2021) that reported a retrospective review of the finnish joint registry from finland that looked at the revision rates and survivorship of vitamin-e infused highly crosslinked polyethylene liners (vepe) compared to moderately crosslinked polyethylene liners.The study consisted of 2 groups with 2,723 hips in the vepe group and 2,707 hips in the reference group.The study group patients were operated on between january 1, 2008 and december 31, 2017, with a mean follow-up time of 5.0 years (0¿9.7).The reference group patients were operated on between january 1, 2000 and december 31, 2017, with a mean follow-up time of 11.0 years (0¿18.5).The study population had a mean age of 67 and 64 years respectively at time of surgery.It was reported in a journal article that 2 patients underwent a revision at an unknown date due to a unknown component fracture.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN STEM
• 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: 13060669
• MDR Text Key: 286660033
• Report Number: 0001825034-2021-03450
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: NI
• 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
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Hospitalization