MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK PERIARTICULAR PROXIMAL; PROSTHESIS, TRAUMA

Catalog Number UNKNOWN PERIARTICULAR PROXIMAL

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

Patient Problem Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-03961.0001822565-2020-03962.0001822565-2020-03963.Full name of device - unk periarticular proximal humeral locking plate.Full name of device - unk periarticular proximal humeral locking plate.Concomitant medical products: unknown fcl screw.Unknown fcl screw.Unknown fcl screw.Foreign report source: (b)(6).Literature - assessment of the ecacy of the far cortical locking technique in proximal humeral fractures: a comparison with the conventional bi-cortical locking technique.Doi: 10.21203/rs.2.22352/v3.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 approximately three (3) weeks ago, a journal article was retrieved from bmc musculoskeletal disorders that reported a retrospective study from (b)(6) that looked at treatment strategies for the management of proximal humeral fractures.The study reported one patient within the fcl group exhibited resorption or migration of the greater tuberosity.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Insufficient information provided.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 cannot be determined.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: UNK PERIARTICULAR PROXIMAL
• Type of Device: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10934623
• MDR Text Key: 219154555
• Report Number: 0001822565-2020-03960
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN PERIARTICULAR PROXIMAL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Other