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

Model Number N/A

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign: country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Miettinen, hannu ja., miettinen, simo sa., kettunen, jukka s.(2020) revision hip arthroplasty using a porous tantalum acetabular component.Hip international 00(0), 1-7.Https://doi.Org/10.1177/1120700020913294.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00922, 0001822565-2021-00923.

Event Description

A journal article was retrieved from hip international (2020) that reported a retrospective study from finland (kuopio university hospital) that looked at the survivorship of tm revision hips.The purpose of the study was to investigate the 10-year survival of trabecular tantalum metal (tm) acetabulum component in revision hip arthroplasty operations and to evaluate complications leading to re-revision.The study reviewed 100 revision hip patients revised with a tm revision shell, unconstrained liner, 28mm head, and monoblock (35 hips) and revision components (65 hips) with additional screws in 45 hips and augmentation in 5 hips.The indication for revision was acetabular loosening (67), liner wear (19), loosening of both components (5), infection (2), protrusion (2), malposition (2), periprosthetic fracture (1), femoral loosening (1), and recurrent dislocation (1).The mean age of the patients at the time of revision was 69.8 (sd 8.0; range 48.0¿91.0) years.The mean follow-up time was 9.4 years and the median was 11.5 years (sd 4.118; range 0.1¿13.4 years).The patients were routinely clinically followed with a 3-month postoperative visit and some patients were seen after that in extra follow-up evaluations from 1¿5 years after the revision surgery.It was reported in a journal article one patient died due to infection complications following revision surgery.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Upon reassessment of the reported event, the stem was determined to be not reportable.The initial report was forwarded in error and should be voided.

Event Description

Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.

• Brand Name: UNK STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11602814
• MDR Text Key: 243548533
• Report Number: 0001822565-2021-00924
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• 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
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN HEAD.; UNKNOWN LINER.; UNKNOWN TM SHELL.
• Patient Outcome(s): Death