MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 GLOBAL AP HUMERAL STEM 12MM; GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS

Catalog Number	113012000
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2018
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
Dr.(b)(6), total shoulder replacement, (b)(6) hospital (b)(6) 2018.The primary tsr took place approximately 10 years ago.Surgeon indicated that the patient had a irreparable rotator cuff and that the humeral component seemed to be loose.The primary components were removed and the surgeon replaced them with a delta reverse shoulder prosthesis.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned device did not find any evidence of malfunction or product error.Review of the device history records did not reveal any related manufacturing deviations or anomalies.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: GLOBAL AP HUMERAL STEM 12MM
• Common Device Name: GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7348326
• Report Number: 1818910-2018-55397
• Device Sequence Number: 952545
• Product Code: HSD
• UDI-Device Identifier: 10603295005520
• UDI-Public: 10603295005520
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2018

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 Catalogue Number: 113012000
• Device Lot Number: C13KD1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 06/06/2018; 12/03/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 06/08/2018; 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR