MAUDE Adverse Event Report: ZIMMER GMBH INVERSE/REVERSE SCREW SYSTEM, 4.5-30; ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

Catalog Number 01.04223.030

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problem No Code Available (3191)

Event Date 08/05/2015

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer's reference number of this file is (b)(4).

Event Description

It was reported that the patient was implanted a inverse/reverse screw system, 4.5-30 on (b)(6) 2014.The patient described a clunking noise and indicated it hindered movement.The surgeon and the patient decided to revise the shoulder.During the revision on (b)(6) 2015 it was determined that the poly had dislodged.The screws were not removed during the revision.

Manufacturer Narrative

During the trend analysis no trend was identified.The compatibility check was performed from surgical technique lit.No.06.01276.012 and showed that the product combination was approved by zimmer biomet.Review of incoming information : the patient described a "clunking" noise and indicated it hindered movement.Dr.(b)(6) and the patient decided to revise the shoulder.During the revision it was determined that the poly had dislodged.The surgeon was concerned that the locking mechanism failed and requested the poly analyzed.Four x-rays with poor quality were provided.The screws could be seen only on two of the four x-rays.It seems that the implant was correctly implanted.In the available surgical reports no inconspicuousness regarding screw implantation could be found.The device analysis could not be performed as the device was not returned for investigation.Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The involved anatomical shoulder inverse/reverse screws were not affected at all.The dislodgment of the pe inlay is related to (b)(4) only.This is a split case with (b)(4).Zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: INVERSE/REVERSE SCREW SYSTEM, 4.5-30
• Type of Device: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
• Manufacturer (Section D): ZIMMER GMBH; sulzerallee 8; winterthur, 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 5742676131
• MDR Report Key: 5024675
• MDR Text Key: 23824225
• Report Number: 9613350-2015-01010
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 01.04223.030
• Device Lot Number: 2711705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2013
• 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): Other
• Patient Age: 70 YR