MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER IMPLANT

Catalog Number UNK SHOULDER LOCKING SCREW

Device Problems Fracture (1260); Loss of Osseointegration (2408)

Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient was revised to address fall and loosening of the metaglene at cement to implant interface.It was also reported that patient likely broke 2 screws from the fall.Surgeon decided to revise patient shoulder and removed the glenospheres, the metaglene base plate, 4 screws, and the humeral cup.The glenoid was filled with bone graft and a delta cta head was implanted onto stem.Doi: (b)(6) 2012; dor: (b)(6) 2019; left shoulder.

Manufacturer Narrative

Product complaint # (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: UNKNOWN SHOULDER LOCKING SCREW
• Type of Device: UNKNOWN SHOULDER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 8703681
• MDR Text Key: 148158925
• Report Number: 1818910-2019-96095
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER LOCKING SCREW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR