MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CROSSLINK ANCHOR PG GLENOID 44; GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID

Model Number 1136-41-026

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Muscular Rigidity (1968); Pain (1994)

Event Date 01/18/2021

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

Patient was revised on (b)(6) 2021 due to loosening of the glenoid at the cement to implant interface.Depuy cement was used.It is noted that patient has had prior arthroscopic evaluation along with manipulation for stiffness and pain.On (b)(6) 2021 patient humeral head was removed and replaced, as well as the 44 glenoid which was cemented with all the pegs including the central peg.Patient underwent a left total shoulder arthroplasty on (b)(6) 2020.A 44 glenoid was implanted at that time.Doi: (b)(6) 2020 dor: (b)(6) 2021 left 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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: CROSSLINK ANCHOR PG GLENOID 44
• 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: 11253246
• MDR Text Key: 229444005
• Report Number: 1818910-2021-02124
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295006978
• UDI-Public: 10603295006978
• 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: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1136-41-026
• Device Catalogue Number: 113641026
• Device Lot Number: J74N60
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CROSSLINK ANCHOR PG GLENOID 44; DEPUY CMW 2 20G; GLOBAL UNITE HEAD 44X18 ECC; CROSSLINK ANCHOR PG GLENOID 44; DEPUY CMW 2 20G; GLOBAL UNITE HEAD 44X18 ECC
• Patient Outcome(s): Required Intervention