MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 4.75 MM FIXED LOCKING SCREW 3.5 HEX; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Fracture (1260); Naturally Worn (2988)

Patient Problems Debris, Bone Shedding (1803); Foreign Body In Patient (2687)

Event Date 10/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 010000589, comprehensive mini baseplate and taper adaptor, 959370, 180552, 4.75 mm fixed locking screw 3.5 hex, 018250, 180553, 4.75 mm fixed locking screw 3.5 hex, 018380, ep-115394, e1 standard +3 mm humeral bearing, 232030, 115316,versa-dial glenosphere +6 mm,657620, 115395,6.5 mm central screw 3.5 hex,104240, 113668,comprehensive humeral stem¿revision,831300, 115370,cobalt chrome standard humeral tray,328150.Foreign country: (b)(6).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 has been reported that patient had initial comprehensive reverse shoulder arthroplasty.Subsequently, patient was revised for the second time after one (1) year post initial surgery due to limited bone stock in the lateral scapula, resulting in baseplate failure.During revision surgery, a broken screw was found which was unable to be removed and hence was retained.Wear was observed on humeral bearing due to the contact of the bearing on the edge of the glenosphere after the baseplate had dislodged.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Reported event was unable to be confirmed due to limited information received from the customer.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.However, a contributing condition could be the noted poor glenoid bone stock.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.

Event Description

No further event information available at the time of this report.

• Brand Name: 4.75 MM FIXED LOCKING SCREW 3.5 HEX
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8078450
• MDR Text Key: 127408721
• Report Number: 0001825034-2018-10741
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K130390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 180550
• Device Lot Number: 151500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2018
• Initial Date FDA Received: 11/16/2018
• Supplement Dates Manufacturer Received: 04/16/2019
• Supplement Dates FDA Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention