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

Model Number N/A

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

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 04/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00434903912, tm reverse humeral stem spacer, 63799301.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 02616.

Event Description

It was reported that a patient underwent an initial shoulder procedure.Subsequently, the patient was revised due to the disassociation of the poly liner from the stem.The liner dissociated from the spacer, and the spacer was removed and replaced.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Cmp-(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated: reported event was unable to be confirmed due to limited information received from the customer.Dhr 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.Other text : not returned to manufacturer.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.

Event Description

It was reported that the patient presented with dislocation approximately four (4) months post-revision of a left total reverse shoulder arthroplasty.During the revision, it was noted that the polyethylene liner had disassociated from the humeral stem/spacer.A new stem, 12mm spacer, and a retentive liner were implanted.

• Brand Name: TM REVERSE HUMERAL POLY LINER/INLAYS
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7513303
• MDR Text Key: 108223052
• Report Number: 0001822565-2018-02617
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121543
• 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,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00434906606
• Device Lot Number: 63610389
• Other Device ID Number: (01) 00889024269224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR