MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL UNITE STD STEM SZ 8; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS

Model Number	1100-08-100
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
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
It was reported that the size 1 epiphysis centered would not fit into the stem.Doi: unk.Dor: (b)(6) 2021.Unk knee.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : product code 110008100, work order (b)(4) was manufactured on 19-jun-21.(b)(4) parts were manufactured per specification and all raw materials met specification.Scrap: there was no scrap associated with this lot.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: there were no non-conformances associated with this lot.

• Brand Name: GLOBAL UNITE STD STEM SZ 8
• Common Device Name: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12526143
• Report Number: 1818910-2021-21009
• Device Sequence Number: 20123816
• Product Code: PHX
• UDI-Device Identifier: 10603295004042
• UDI-Public: 10603295004042
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K170748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1100-08-100
• Device Catalogue Number: 110008100
• Device Lot Number: 9814515
• 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: 09/03/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2021
• 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 UNITE STD STEM SZ 8; UNK SHOULDER HUMERAL SIZE 1 EPIPHYSIS; GLOBAL UNITE STD STEM SZ 8; UNK SHOULDER HUMERAL SIZE 1 EPIPHYSIS
• Patient Sex: Unknown