MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ANATOMICAL LOCKING PLATE SYSTEM-PROXIMAL HUMERAL PLATING; TRAUMA IMPLANT

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign source: norway.Https://doi.Org/10.1186/s13018-022-02947-3.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.

Event Description

It was reported in a journal article that was retrieved from the journal of orthopaedic surgery and research from a study from norway.The purpose of the study was to investigate whether the use of blunt pegs instead of pointed screws reduced the risk of penetration into the glenohumeral joint during fracture healing after operatively treated proximal humerus fractures.The study reviewed two groups, anatomical locking plate system-proximal humeral plating (zimmer biomet alps-php) and the proximal humeral internal locking system (syntheses solothurn, switzerland philos).It was reported that one patient underwent implantation of an alps-php following a proximal humeral fracture.Subsequently, the patient underwent removal of one locking peg due to loosening, without signs of non-union or infection.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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 additional event information to report at this time.

• Brand Name: ANATOMICAL LOCKING PLATE SYSTEM-PROXIMAL HUMERAL PLATING
• Type of Device: TRAUMA IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15700727
• MDR Text Key: 302714213
• Report Number: 0001825034-2022-02468
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2023
• 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): Required Intervention; Hospitalization