MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OFFSET MODULAR HUMERAL HEAD 18 MM; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Pain (1994); Weakness (2145); Shaking/Tremors (2515)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr¿s were submitted for this event.Please see reports: 0001822565 - 2017 - 06761, 0001822565 - 2017 - 06763.Concomitant medical products: 00430008700, glenoid component-pegged 52 mm, lot# 62459668; 00430205218, offset modular humeral head 18 mm, lot# 62480079; 00434811613, humeral stem 48 degrees 16 mm, lot# 62445793.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

It was reported the patient is experiencing weakness and shaking while in extension.It was stated the subscapularis is deficient and it may have snapped back, not holding everything in place.The humeral bone has now migrated up.It has not been indicated the patient has been revised.No further information has been made available.

Manufacturer Narrative

This follow up report is being submitted to report additional information reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history determined that no further action is required as no trends were identified.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: OFFSET MODULAR HUMERAL HEAD 18 MM
• 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: 6909882
• MDR Text Key: 88008488
• Report Number: 0001822565-2017-06762
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK103404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00430205218
• Device Lot Number: 62480079
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2013
• 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 Weight: 95