MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOID COMPONENT; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problems Detachment Of Device Component (1104); Unstable (1667)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Sleep Dysfunction (2517)

Event Date 09/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the patient presented six years post primary implantation with sharp and severe right shoulder pain with weight bearing, instability, pain with overhead activity, radiating pain, night pain, limited range of motion, and swelling.Subsequently, the patient was revised to address a complete disassociation of the glenoid component along with cement and some bone; displaced subdeltoid.The glenoid was removed and the glenoid vault was bone grafted and a new head was implanted.No further information has been made available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was able to be confirmed via operative notes.Two pictures of glenoid and head were also provided for evaluation.Both devices have blood stains.Glenoid has some tissue and bone cement on the back.Device history record (dhr) was reviewed and no discrepancies were found.Review of complaint history determined that no further action is required.Root cause was unable to 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.

• Brand Name: GLENOID COMPONENT
• Type of Device: PROSTHESIS, EXTREMITY
• 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: 6954297
• MDR Text Key: 89475383
• Report Number: 0001822565-2017-07125
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK982981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00430008200
• Device Lot Number: 61634976
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2011
• 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
• Treatment: (B)(4) OFFSET MODULAR HUMERAL HEAD LOT 614482; (B)(4) MODULAR HUMERAL STEM LOT 61796220
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 103