MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL AP PC STEM 8 MM; GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS

Catalog Number	113008200
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Revision of left shoulder hemi arthroplasty -patient experiencing pain, plan to revise to a total shoulder (add glenoid component and replace head and taper), but surgeon found head was sitting too high, so removed stem and replaced with a new stem, sinking it to a better position original surgery 2 or so years ago - exact date was not available doe: (b)(6) 2024.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information was received: a.Was there any patient consequence related to the event.- we revised the shoulder as described in the pc.B.Was there any surgical delay related to the event? - surgical delay question is not really applicable as the entire surgery was a revision.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : revision of left shoulder hemi arthroplasty -patient experiencing pain, plan to revise to a total shoulder (add glenoid component and replace head and taper), but surgeon found head was sitting too high, so removed stem and replaced with a new stem, sinking it to a better position original surgery done by dr.(b)(6) 2 or so years ago - exact date was not available.The product was not returned to depuy synthes, however photos were provided for review.See attachment (b)(4).The x-ray investigation revealed nothing indicative of a device nonconformance, based on the information provided we cannot confirmed that the device has been mispositioned, the device was surrounded by fibrous tissue which is consistent with tissue ingrowth suggesting a good fixation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the global ap pc stem 8 mm would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the lot number provided was invalid also was not clearly visible due to the poor quality of the photo therefore, a manufacturing records evaluation (mre) was not performed.

• Brand Name: GLOBAL AP PC STEM 8 MM
• Common Device Name: GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18836369
• Report Number: 1818910-2024-04988
• Device Sequence Number: 7245987
• Product Code: HSD
• UDI-Device Identifier: 10603295005483
• UDI-Public: 10603295005483
• 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 Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 113008200
• Device Lot Number: 180666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2024
• Supplement Date Received by Manufacturer: 03/20/2024; 05/21/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 03/20/2024; 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL UNITE HEAD 52X15 ECC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown