MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN MILLER/GALANTE UNICOMPARTMENTAL ARTICULAR SURFACE; PROSTHESIS, KNEE

Catalog Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 03/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Gro s.Dyrhovden (2017) "have the causes of revision for total and unicompartmental knee arthroplasties changed during the past two decades?" clinical orthopaedics and related research, 475:1874¿1886.Concomitant devices ¿ unknown miller/galante unicompartmental tibial component catalog #: ni lot #: ni, unknown miller/galante unicompartmental femoral component catalog #: ni lot #: ni.Contact name ¿ this journal article was written by gro s.Dyrhovden, stein hakon l.Lygre, mona badawy, oystein gothesen and ove furnes.The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.The reported event was unable to be confirmed due to limited information received from the customer.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A complaint history review was unable to be performed as the part and lot numbers are unknown.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.This report is number 1 of 3 mdrs filed for the same event (reference 0001822565-2017-05623 / 05624).

Event Description

It is reported in a journal article that 176 patients underwent knee arthroplasty revisions to treat unexplained pain.No further patient consequences were reported.Attempts have been made to retrieve additional information, but no further information is available at this time.

• Brand Name: UNKNOWN MILLER/GALANTE UNICOMPARTMENTAL ARTICULAR SURFACE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6788768
• MDR Text Key: 82559873
• Report Number: 0001822565-2017-05622
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2017
• 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