MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP NLK SCR 3.5HEX 4.75X15 ST; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Detachment Of Device Component (1104); Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 09/21/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 180551, comp lk scr 3.5hex 4.75x20 st, 664220, 180551, comp lk scr 3.5hex 4.75x20 st, 731520, 115382, comp rvs cntrl scr 6.5x30mm st, 877000, 010000589, comp rvrs 25mm bsplt ha+adptr, 246500, 115370, comp rvs tray co 44mm, 848480, 113618, comp primary stem 18mm micro, 661170, xl-115363, arcom xl 44-36 std hmrl brng, 478500, 405889, comp rvs 2.7mm dia drl, 055780, 115310, comp rvrs shldr glnsp std 36mm, 933470, 180557, comp nlk scr 3.5hex 4.75x15 st, 452670, 405800, comp.Rev shldr 9 in steinmann, 132910, 180551, comp lk scr 3.5hex 4.75x20 st, 731520, 180551, comp lk scr 3.5hex 4.75x20 st, 664220, 405883, comp rvs 3.2mm drl, 04_310.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 03160, 0001825034 - 2018 - 03159, 0001825034 - 2018 - 02448, 0001825034 - 2018 - 02449.Product location unknown.

Event Description

It was reported by the patient¿s legal counsel that the patient underwent right shoulder arthroplasty.Subsequently, the patient was revised due to a central screw fracture, a loose glenosphere, and screw migration.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes.Dhr was reviewed and no discrepancies relevant to the reported event 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.

Event Description

It was reported by the patient¿s legal counsel that the patient underwent right shoulder arthroplasty.Subsequently, the patient was revised due to a central screw fracture and a loose, disassociated glenosphere.During the revision, it was found that the screws had migrated and cut out the posterior glenoid.The patient was converted to a hemi-arthroplasty.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: COMP NLK SCR 3.5HEX 4.75X15 ST
• 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: 7524394
• MDR Text Key: 108605321
• Report Number: 0001825034-2018-03161
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 180557
• Device Lot Number: 452670
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2013
• 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 Age: 81 YR