MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 46X18X53 HUM HEAD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Tissue Damage (2104); No Information (3190)

Event Date 03/01/2018

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 that the patient was revised due to anterior instability related to failure of subscapularis repair.Patient was converted to a reverse shoulder; the humeral stem was left insitu.It was reported the surgeon has questioned whether an initial, oversized humeral head contributed to the failure of the subscapularis repair.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was confirmed through x-rays received.The surgeon questioned if an oversized head was used, which could have contributed.This, however, was unable to be confirmed.X-ray review noted: "possible demineralized proximal humerus bone circumferentially (zones 1, 7), but uncertain if this is this is artifactual.There is posterior subluxation of the humerus which could be related to pathology of the joint capsule or potentially atrophy/weakening of support muscles." dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: VERSA-DIAL 46X18X53 HUM HEAD
• Type of Device: PROSTHESIS, SHOULDER
• 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: 7403909
• MDR Text Key: 104597946
• Report Number: 0001825034-2018-02292
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK040610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 113042
• Device Lot Number: 307970
• Other Device ID Number: (01) 00880304212220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2016
• 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) PT HYBRID GLEN POST, LOT 670840; (B)(4) SM HYBRID GLENOID, LOT 025250; (B)(4) VERSA-DIAL/COMP TI STD TAPER, LOT 223180
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR