MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE COLLAR SZ 52; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Model Number	1100-20-400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
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 patient told surgeon that he wasn't having a lot of pain but wasn't getting the rom that he had been getting.This patient had a left hemi shoulder replacement done for a fracture back on (b)(6) 2015.The surgeon thought that maybe he had over-stuffed the joint and wanted to remove the head/collar and put on a smaller head.The surgeon removed the head/collar and trialed with a 44 head.He said that he felt that it improved the stability.He then closed the patient up and was happy with the result.The surgeon felt he needed to downsize the head so stability and lack of rom was the main issue from what i understood talking with the surgeon.No loosening and surgical delay noted.Doi: (b)(6) 2015, dor: (b)(6) 2020, left shoulder.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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 lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: GLOBAL UNITE COLLAR SZ 52
• Common Device Name: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11003597
• Report Number: 1818910-2020-26868
• Device Sequence Number: 3699367
• Product Code: KWS
• UDI-Device Identifier: 10603295004288
• UDI-Public: 10603295004288
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K170748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• 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): 12/01/2020

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 Model Number: 1100-20-400
• Device Catalogue Number: 110020400
• Device Lot Number: 3555408
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 01/12/2021
• 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: GLOBAL UNITE HEAD 52X18 STD; GLOBAL UNITE HEAD 52X18 STD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR