MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE CENTRAL SCREW 6.5MM; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Disassembly (1168)

Patient Problem No Code Available (3191)

Event Date 08/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Concomitant products: 115313, comp rvsr shldr glnsp +3 36mm, 295770.118000, 25mm versa-dial taper adaptor, 916240.00435006500, 65 d ret 36mm vit e lnr +0mm, unk.115313, comp rvsr shldr glnsp +3 36mm, unk.118000, 25mm versa-dial taper adaptor, unk.00435006506, 65 d ret 36mm vit e lnr +6mm, 62847889.Report source, foreign ¿ events occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 07552; 0001825034-2017-07553.

Event Description

It was reported that the patient underwent a total reverse shoulder arthroplasty.Subsequently, the patient was revised due to disassociation of the glenosphere.During the revision, the glenosphere and poly were removed and replaced.It was noted by the surgeon that the center screw for the baseplate could be rotated, indicating it may not have been fully inserted during the primary procedure, thus contributing to the disassociation.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the intial medwatch.

Event Description

It was reported that patient underwent a right reverse shoulder arthroplasty.Subsequently, the patient was revised due to disassociation of the glenosphere.During the revision, the glenosphere and poly were removed and replaced.It was noted by the surgeon that a center screw for the baseplate could be rotated two or three, so it might not have been fully inserted at primary, contributing to the disassociation.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).Concomitant medical products: 00435006506, 65 d ret 36mm vit e lnr +6mm, lot # 62847889v; 115313, comp rvsr shldr glnsp +3 36mm, lot # 295770; 180550, comp lk scr 3.5hex 4.75x15 st, lot # 965490; 180551, comp lk scr 3.5hex 4.75x20 st, lot # 771980; 180555, comp lk scr 3.5hex 4.75x40 st, lot # 374160; 180560, comp nlk scr 3.5hex 4.75x30 st, lot # 251780; 00434901013, humeral stem 10 mm stem diameter 130 mm stem length, lot # 63508925.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.No screws were returned for evaluation.The poly, taper and glenosphere were returned for evaluation and visual inspections identified only cosmetic defects, such as scratches.X-ray review: current x-rays do not show definite signs of screw loosening or backing out; however, superior off-set of the glenosphere could be consequence of component loosening.This assessment is limited by lack of earlier x-rays showing initial surgical position of the screws and glenosphere.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: COMPREHENSIVE CENTRAL SCREW 6.5MM
• 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: 6904707
• MDR Text Key: 87789979
• Report Number: 0001825034-2017-07604
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK080642
• 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,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 115381
• Device Lot Number: 989920
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2017
• 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: 79 YR