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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL AP PC STEM 12 MM; GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS
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DEPUY ORTHOPAEDICS INC US GLOBAL AP PC STEM 12 MM; GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS Back to Search Results
Model Number 1130-12-200
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 07/22/2021
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
Right total shoulder removed for prostalac spacer because of infection.Implanted approximately 10 years ago.No other information available.
 
Additional 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.
 
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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 Key12468700
Report Number1818910-2021-20052
Device Sequence Number3821689
Product Code MBF
UDI-Device Identifier10603295005544
UDI-Public10603295005544
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K063652
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 08/24/2021
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 Number1130-12-200
Device Catalogue Number113012200
Device Lot Number480671
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/24/2021
Supplement Date Received by Manufacturer10/11/2021
Initial Report FDA Received Date09/14/2021
Supplement Report FDA Received Date10/12/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
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
Outcome Attributed to Adverse Event Required Intervention;
Patient Age48 YR
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