MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL UNITE HEAD 52X18 ECC; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS

Model Number 1100-52-610

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscular Rigidity (1968); Pain (1994)

Event Date 01/01/2021

Event Type  Injury  

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 Description

Pt is being revised for chronic pain and stiffness.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: GLOBAL UNITE HEAD 52X18 ECC
• Type of Device: GLOBAL UNITE IMPLANTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11247546
• MDR Text Key: 229306250
• Report Number: 1818910-2021-02022
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295004738
• UDI-Public: 10603295004738
• Combination Product (y/n): N
• PMA/PMN Number: K101996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

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
• Device Operator: Health Professional
• Device Model Number: 1100-52-610
• Device Catalogue Number: 110052610
• Device Lot Number: 702403
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL AP HUMERAL STEM 14MM; GLOBAL UNITE HEAD 52X18 ECC; GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL AP HUMERAL STEM 14MM; GLOBAL UNITE HEAD 52X18 ECC
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR