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

Model Number N/A

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

Patient Problem Sepsis (2067)

Event Type  Injury  

Manufacturer Narrative

(b)(4).O'neill cj et al.Acetabular revision using trabecular metal augments for paprosky type 3 defects.The journal of arthroplasty 33.2017: 823-828.No product, pictures, or medical records were provided for review.A review of the device history records was unable to be performed as the part and lot information was 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.Concomitant medical product(s): unknown tm augment.Report source: event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3005751028 - 2020 - 00041.

Event Description

It was reported from a journal article that in an unknown timeframe postoperatively, two patients developed recurrence of deep sepsis and required a 2-stage revision.No further information has been made available from this study.

• Brand Name: UNKNOWN TM REVISION 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: 9995807
• MDR Text Key: 188934738
• Report Number: 3005751028-2020-00042
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/24/2020

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 04/24/2020
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention