MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK LINER; PROSTHESIS, EXTREMITIES

Catalog Number UNK LINER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Embolism (1498)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: mia s.Hagen, md, sachin allahabadi, md, alan l.Zhang, md, brian t.Feeley, md, trevor grace, md, c.Benjamin ma, md (2019).A randomized single-blinded trial of early rehabilitation versus immobilization after reverse total shoulder arthroplasty, journal of shoulder and elbow arthroplasty.Volume 29, issue 3, p442-450, https://doi.Org/10.1016/j.Jse.2019.10.005.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01230, 0001822565-2020-01232, 0001822565-2020-01234.No product was returned; visual and dimensional evaluations could not be performed.Unable to perform a compatibility check.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause could not be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

The study reported one patient within the immediate-therapy group experienced a postoperative pulmonary embolism.Attempts have been made and no further information has been provided.

• Brand Name: UNK LINER
• Type of Device: PROSTHESIS, EXTREMITIES
• 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: 9934430
• MDR Text Key: 187393123
• Report Number: 0001822565-2020-01233
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK LINER
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2020
• 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: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Other