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 Problems Loss of or Failure to Bond (1068); Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).(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

This was a revision of a global unite anatomic total shoulder replacement, and converted to a delta xtend reverse total shoulder replacement due to rotator cuff failure and instability.The stem was well fixed and was retained, but the proximal body (110040000), head (114400600), and glenoid component (113641026) needed to be removed in order to perform the conversion procedure.I am unsure when the primary surgery was done.Unable to get the lot number for the proximal body (110040000).When the glenoid component glenoid component (113641026) was removed one of the peripheral pegs broke off which was then removed.The surgeon noted that this component was actually loose.He said this will have been caused by the instability of the shoulder exerting rocking forces on the glenoid component, and eventually loosening glenoid implant.This is because the cuff was deficient.

Event Description

Additional information received stating that they cannot confirm what cement was used.Simplex is most commonly used on the glenoid.The rotator cuff failure was due to natural progression.Affected side: left side.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination, however a photo was provided for review confirming the reported fracture.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).Where the lot code was provided, 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: 10809805
• MDR Text Key: 215483465
• Report Number: 1818910-2020-24187
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• 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: J0493D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GLBL UNITE ANT BODY 135 SZ 12.; GLOBAL UNITE HEAD 44X15 ECC.
• Patient Outcome(s): Required Intervention