MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REV HUMERAL POLY LINER/INLAYS; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)

Patient Problems Loss of Range of Motion (2032); Joint Dislocation (2374); No Code Available (3191)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown, unknown stem, unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a revision procedure approximately eighteen months post-implantation due to poly dissociated from stem.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.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 underwent a revision procedure approximately twenty-three (23) months post-implantation due to loss of shoulder function.It was discovered that the polyethylene liner had dissociated from the stem and the patient experienced associated dislocation.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown 14x130 cemented humeral stem, unknown glenoid head, unknown glenoid baseplate.

• Brand Name: TM REV HUMERAL POLY LINER/INLAYS
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7480517
• MDR Text Key: 107142302
• Report Number: 0001822565-2018-02394
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: PK121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00434906506
• Device Lot Number: 63295422
• Other Device ID Number: (01) 00889024269194
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR