MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVSR SHLDR GLNSP +3 36MM; SHOULDER, PROSTHESIS

Catalog Number 115313

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-07062, 0001825034-2017-09990, 0001825034-2017-09988.(b)(4).Concomitant medical products: catalog#010000589 comp rvrs 25 mm bsplt ha+adptr lot# 588290.Catalog#115313 comp rvsr shldr glnsp +3 36 mm lot#507470.Catalog# ep-115394 e1 44-36 std +3 hmrl brg lot#337240.Catalog# 115370 comp rvs tray co 44 mm lot# 095430.Catalog# 113632 comp primary stem 12 mm mini lot# 629610.Catalog# 115398 comp rvs cntrl 6.5 x 40 mm st/rst lot#338580.Catalog#180553 comp lk scr 3.5hex 4.75 x 30 st lot#587170.Catalog# 180551 comp lk scr 3.5hex 4.75 x 30 st lot#320450.Catalog#180559 comp nlk scr 3.5hex 4.75 x 25 st lot# 073230.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no trends were identified.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.

Event Description

It was reported that the patient had an initial right shoulder arthroplasty.Subsequently, the patient has been indicated for a revision surgery due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.

• Brand Name: COMP RVSR SHLDR GLNSP +3 36MM
• Type of Device: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell dr.; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7006160
• MDR Text Key: 91233198
• Report Number: 0001825034-2017-09987
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 115313
• Device Lot Number: 507470
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2016
• 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