MAUDE Adverse Event Report: ZIMMER TMT UNKNOWN ACETABULAR SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problem Osseointegration Problem (3003)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: unknown acetabular augment; unknown femoral stem; unknown femoral head; unknown acetabular liner.Report source: (b)(6).No product was returned; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause could not be determined.O'neill, c.J., creedon, s.B., brennan, s.A., o'mahony, f.J., lynham, r.S., guerin, s.,.Harty, j.A.(2018).Acetabular revision using trabecular metal augments for paprosky type 3 defects.Results of total hip arthroplasty after core decompression with tantalum rod for osteonecrosis of the femoral head, 33, 823-828.Doi:https://doi.Org/10.1016/j.Arth.2017.10.031.Multiple mdr reports were filed for this event, please see associated reports: 3005751028-2020-00046, 3005751028-2020-00047.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

A journal article reported one patient from the augment only group who underwent revision due to aseptic loosening.

• Brand Name: UNKNOWN ACETABULAR SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: william hara ; 10 pomeroy road; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 10003106
• MDR Text Key: 191916082
• Report Number: 3005751028-2020-00047
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2018
• 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): Hospitalization; Required Intervention