MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN LINER; PROTHESIS, SHOULDER

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 03755.Customer has not indicated that the product will be returned to zimmer biomet for investigation or not.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported that patient underwent reverse shoulder arthroplasty combined with a latissimus dorsi tendon transfer.Subsequently patient was revised due to instability.During the revision, the baseplate was revised and the humeral poly was noted to be disassociated with medial wear.

Manufacturer Narrative

(b)(4).Upon reassessment, it was identified that the report was inadvertently submitted under the wrong mfr.A new report will be submitted under mfr: 0001822565-2018-03375.

• Brand Name: UNKNOWN LINER
• Type of Device: PROTHESIS, 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: 7562593
• MDR Text Key: 109880482
• Report Number: 0001825034-2018-03754
• Device Sequence Number: 1
• Product Code: MJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 68 YR