MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER NON-LOCKING SCREW

Catalog Number UNK SHOULDER NON-LOCKING SCREW

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

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

Event Date 11/11/2019

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

The patient was revised to address loosening of the unknown component at the bone to implant interface.It was also reported that the patient had their shoulder done sometime around 2005.The surgeon wasn't sure of the exact date.The glenosphere failed and ripped out of the patients glenoid.The glenosphere came out in one piece.They were unable to identify the metaglene used, or the screw sizes that were removed.The surgeon was able to use a zimmer biomet augmented glenosphere, but wanted to maintain the humeral component.The sales rep informed him that it was off label to mix components, but he decided it was best for the patient.After he inserted their glenosphere, a trial reduction was performed with a 9mm spacer and 9mm poly.The 9mm spacer was opened and implanted, then he decided on using a 6mm poly.The shoulder was reduced and found to be satisfactory.The closing process began.Doi: 2005; dor: (b)(6) 2019; right shoulder.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN SHOULDER NON-LOCKING SCREW
• Type of Device: SHOULDER NON-LOCKING SCREW
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 9413150
• MDR Text Key: 169200841
• Report Number: 1818910-2019-120393
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER NON-LOCKING SCREW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 66