MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS SHLDR GLNSP STD 36MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 06/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product device code - phx.(b)(4).Concomitant medical products: cp560865, 3.5x30mm bone screw, lot 699380; cp560869, 3.5x50 mm bone screw, lot 699420; 103533, 6.5x30 mm low profile screw, lot 348740; 113862, 5x30 mm low profile screw, lot 517310; cp560867, 3.5x40 mm bone screw, lot 699400; cp560863, 3.5x20 mm bone screw, lot 742010; cp560864, 3.5x25 mm bone screw, lot 699370; cp560866, 3.5x35 mm bone screw, lot 699390; cp560861, 3.5x10 mm bone screw, lot 699340; xl-115363, arcom xl 44-36 std hmrl brng, lot 386490; 115370, comp rvs tray, lot 648710; 115310, comp rvrs shldr glnsp, lot 594180; 118001, taper, lot 388050; 180552, screw, lot 612100; 180552, screw, lot 938320; 180553, screw, lot 425770; 180551, screw, lot 748420; 115397, comp rvs ccntrl 6.5x35mm st/rst, lot 193820; pm555334, lt pm rvs glen, lot 429540; 211219, compr srs prox bdy, lot 652520; 211218, comp srs prox bdy, lot 539740.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2016-01159.

Event Description

It was reported that approximately 4 months post implantation, the patient underwent a revision due to dislocation and instability.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.No devices, photos, or medical records were received for this event.Device history record (dhr) was reviewed and no discrepancies were found.Root cause could not be determined based on the information provided, however, it should be noted that this patient is a rancher who never stopped working, and could contribute to the issues.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

No further event information available at the time of this report.

• Brand Name: COMP RVRS SHLDR GLNSP STD 36MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8221687
• MDR Text Key: 132207500
• Report Number: 0001825034-2018-11413
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• PMA/PMN Number: K080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 115310
• Device Lot Number: 594180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention