MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL AP HUMERAL HEAD 52X18; GLOBAL AP IMPLANTS : SHOULDER HUMERAL HEADS

Model Number	1130-52-510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	06/24/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The patient present in the doctor's office with a painful left shoulder and a decrease in range of motion.Surgeon ordered a series of studies and formed the opinion that the index glenoid component was loose.The surgeon revised the shoulder.Upon exposure to the joint space, dr.Removed the 52x18 standard humeral head for the ap should system, and the 135 tapered spacer with the standard head removal fork in the global ap trays.The size 10 global ap standard stem was kept implanted.Surgeon then easily removed the 52 anchor peg glenoid with a pair of kochers.Due to bone loss, surgeon then implanted a competitive glenoid.No instrumentation broke during surgery and there were no delays.
Additional 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: GLOBAL AP HUMERAL HEAD 52X18
• Common Device Name: GLOBAL AP IMPLANTS : SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10240917
• Report Number: 1818910-2020-15175
• Device Sequence Number: 2841681
• Product Code: KWS
• UDI-Device Identifier: 10603295006237
• UDI-Public: 10603295006237
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K060874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1130-52-510
• Device Catalogue Number: 113052510
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GLOBAL ANCHOR PEG GLENOID 52 MM; GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL AP HUMERAL STEM 10 MM; GLOBAL ANCHOR PEG GLENOID 52 MM; GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL AP HUMERAL STEM 10 MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 105