MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CROSSLINK ANCHOR PG GLENOID 52; GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID

Model Number 1136-43-026

Device Problem Naturally Worn (2988)

Patient Problems Fall (1848); No Code Available (3191)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

It was reported that the patient stated that a year after his surgery, he fell.A torn subscap was discovered as the reason for a loose component.Glenoid was worn due to this soft tissue lax and was removed.Head was also replaced with a larger head to help tighten the space.Doi: (b)(6) 2016, dor: (b)(6) 2020, right shoulder.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary :no device associated with this report was 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.

• Brand Name: CROSSLINK ANCHOR PG GLENOID 52
• Type of Device: GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10320082
• MDR Text Key: 200223873
• Report Number: 1818910-2020-16799
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295007012
• UDI-Public: 10603295007012
• Combination Product (y/n): N
• PMA/PMN Number: K052472
• 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: 07/14/2020

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: 1136-43-026
• Device Catalogue Number: 113643026
• Device Lot Number: C20378
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 08/28/2020
• Supplement Dates FDA Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CROSSLINK ANCHOR PG GLENOID 52; GLOBAL ADVANTAGE ECC HD 52X18; CROSSLINK ANCHOR PG GLENOID 52; GLOBAL ADVANTAGE ECC HD 52X18
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR