MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLBL UNITE ANT BODY 135 SZ 12; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Model Number	1100-40-000
Health Effect - Clinical Codes	Adhesion(s) (1695); Fatigue (1849); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/16/2020
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
Clinical adverse event received for stiffness - s/p tsa: arthrofibrosis.Event is serious and is considered moderate.Event is definitely not related to device and is possibly related to procedure.Date of implantation: (b)(6) 2018.Date of event (onset): (b)(6) 2020.(left shoulder).Treatment: patient underwent manipulation under anesthesia, transarthroscopic lysis of adhesions and capsular release.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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.H10 additional narrative: 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
Medical records received and reviewed: it is noted the date of left shoulder manipulation under anesthesia occurred on (b)(6) 2020.In addition to the previously reported issues, the patient was also experiencing the following adverse symptoms prior to left shoulder manipulation under anesthesia on (b)(6) 2020: pain, discomfort, decreased range of motion, and weakness.Evaluation notes following the left shoulder manipulation revealed improving symptoms.

• Brand Name: GLBL UNITE ANT BODY 135 SZ 12
• Common Device Name: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11176063
• Report Number: 1818910-2021-01205
• Device Sequence Number: 19420638
• Product Code: HSD
• UDI-Device Identifier: 10603295004417
• UDI-Public: 10603295004417
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2021

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 Number: 1100-40-000
• Device Catalogue Number: 110040000
• Device Lot Number: 8878602
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 02/17/2021; 03/01/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 02/25/2021; 03/02/2021
• 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: CROSSLINK ANCHOR PG GLENOID 52; DEPUY/CMW 2G; GLBL UNITE ANT BODY 135 SZ 12; GLOBAL UNITE HEAD 52X21 ECC; GLOBAL UNITE STD STEM SZ 12; CROSSLINK ANCHOR PG GLENOID 52; DEPUY/CMW 2G; GLBL UNITE ANT BODY 135 SZ 12; GLOBAL UNITE HEAD 52X21 ECC; GLOBAL UNITE STD STEM SZ 12
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 96