MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL AP PC STEM 12 MM; GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS

Model Number 1130-12-200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/22/2021

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

Right total shoulder removed for prostalac spacer because of infection.Implanted approximately 10 years ago.No other information available.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The investigation could not verify or identify any product contribution to the reported event with the information provided.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: GLOBAL AP PC STEM 12 MM
• Type of Device: GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12468700
• MDR Text Key: 271307692
• Report Number: 1818910-2021-20052
• Device Sequence Number: 1
• Product Code: MBF
• UDI-Device Identifier: 10603295005544
• UDI-Public: 10603295005544
• Combination Product (y/n): N
• PMA/PMN Number: K063652
• 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: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1130-12-200
• Device Catalogue Number: 113012200
• Device Lot Number: 480671
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CROSSLINK ANCHOR PG GLENOID 48; GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL AP HUMERAL HD 48X15 ECC; GLOBAL AP PC STEM 12 MM; CROSSLINK ANCHOR PG GLENOID 48; GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL AP HUMERAL HD 48X15 ECC; GLOBAL AP PC STEM 12 MM
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR