MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2020-03-04 for HUMERAL HEAD SIZE 46 114020046 manufactured by Depuy Orthopaedics Inc Us.
[188870475]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[188870476]
Clinical adverse event received for pain and stiffness left shoulder. Event is not serious and is considered mild. Event is possibly related to both device and is definitely related to procedure.. Date of implantation: (b)(6) 2019. Date of event (onset): (b)(6) 2020. (left shoulder). Treatment: medical intervention/modification (unspecified): yes. Diagnostic intervention (unspecified): yes. Physical therapy: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-06877 |
| MDR Report Key | 9788496 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2020-03-04 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2017-09-08 |
| Date Added to Maude | 2020-03-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUMERAL HEAD SIZE 46 |
| Generic Name | SHOULDER HUMERAL HEADS |
| Product Code | HSD |
| Date Received | 2020-03-04 |
| Catalog Number | 114020046 |
| Lot Number | HG1069 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-04 |