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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Muscular Rigidity (1968); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Events reported in 1818910-2021-04888, 1818910-2021-05553, 1818910-2021-05554, 1818910-2021-05555, 1818910-2021-05556.(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
This case is logged to capture the revision mentioned in (b)(4).The base of the handle of the stem inserter became loose, allowing it to slide down the shaft of the inserter, after the surgeon hammered it (in the correct location) in an attempt to remove a stem.This occurred during a revision case where a global ap was being removed.The surgeon was able to use other instruments within our shoulder extraction trays to successfully remove the stem and complete the operation successfully.The revision was due to the patient experiencing stiffness due to arthrofibrosis with a small degree of cuff damage.The cause of the revision did not have anything to do with the implants themselves right shoulder.
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.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 product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: GLOBAL AP PC STEM 12 MM
• Common Device Name: GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11528223
• Report Number: 1818910-2021-05555
• Device Sequence Number: 4498524
• Product Code: MBF
• UDI-Device Identifier: 10603295005544
• UDI-Public: 10603295005544
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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: 1130-12-200
• Device Catalogue Number: 113012200
• Device Lot Number: HH4303
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 05/27/2021
• 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: CROSSLINK ANCHOR PG GLENOID 48; GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL AP PC STEM 12 MM; GLOBAL UNITE HEAD 48X18 ECC; CROSSLINK ANCHOR PG GLENOID 48; GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL AP PC STEM 12 MM; GLOBAL UNITE HEAD 48X18 ECC
• Outcome Attributed to Adverse Event: Required Intervention