MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BIO-MODULAR PEGGED GLENOID; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date was in 2006.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.

Event Description

It is reported that the patient underwent an initial right shoulder arthroplasty on an unknown date.Approximately 11 years subsequent, the patient was revised due to glenoid component loosening.No further serious injury has been reported, and no other information is available.

Manufacturer Narrative

Date of event/onset - unknown date in (b)(6) 2017.Medical product: bio-modular shoulder humeral with alignment hole, catalog#: 11-113709, lot#: 874110; bio-modular shoulder glenoid component, catalog#: 113722, lot#: 074400.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The reported device (bio-modular shoulder system ¿ glenoid) was returned, stem and humeral head were also returned.Because the glenoid would naturally become deformed to some extent during implantation and explantation, dimensional analysis was not performed.Each of the returned items shows significant cosmetic damage (scratches and gouges).This is likely from implantation and / or explantation.The pegged surface of the glenoid shows very little (if any) cement residue.This confirms the complaint of loosening.While it is not known whether the surgical technique was followed, it can be inferred that it was based on the fact that the bearing surface shows even wear, and the fact that there are no medical records indicating problems during the nearly ten (10) years between implantation and revision.Dhr was reviewed and no discrepancies were found.Complaint history review determined that no further action(s) is/are required.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Based on the review of manufacturing records and complaint history, the device is believed to have been conforming to print when leaving zimmer biomet control.The root cause could not be determined.

• Brand Name: BIO-MODULAR PEGGED GLENOID
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6477062
• MDR Text Key: 72270249
• Report Number: 0001825034-2017-02426
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK992119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2017

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2008
• Device Model Number: N/A
• Device Catalogue Number: 113874
• Device Lot Number: 004290
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2017
• Initial Date FDA Received: 04/10/2017
• Supplement Dates Manufacturer Received: 08/07/2017; 09/20/2017
• Supplement Dates FDA Received: 08/28/2017; 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2003
• 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: 57 YR
• Patient Weight: 75