MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BASE PLATE 15 MM POST LENGTH UNCEMENTED; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during an initial reverse shoulder arthroplasty, the instrument did not disengage from the implant.A new implant was used to completed the procedure.No impact to the surgery or patient was noted.No additional information is made available.

Event Description

No additional information is available to report at this time.

Manufacturer Narrative

The follow up report is being submitted to relay additional information received complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned complaint sample shows the tm is smeared and shows embedded bio debris.Dimensional analysis was performed on the returned device, and device was found to be conforming to print specifications.Cmm report shows that all features are found to be confirming except one taper feature.However, the features that interface with the baseplate inserter were measured 100% on cmm at the time of manufacture.This was likely due to damage caused during the case, when the device jammed.Dhr was reviewed, and no discrepancies were found.A definite root cause cannot be determined with the information provided.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.

• Brand Name: BASE PLATE 15 MM POST LENGTH UNCEMENTED
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8311321
• MDR Text Key: 135211443
• Report Number: 0001822565-2019-00285
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00434901500
• Device Lot Number: 64057125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 03/20/2019
• Supplement Dates FDA Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSTRUMENT; UNKNOWN INSTRUMENT