MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-25 for DXTEND STAND PE CUP D42 +3MM 130742203 manufactured by Depuy France Sas - 3003895575.
[186703925]
(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
[186703926]
Reason for revision: instability. Patient has been experiencing "clunking, feeling of looseness" in his prosthetic shoulder joint, over last 6 months. Patient had been also treated (conservatively, with long term oral antibiotics) for a wound infection. During surgery, surgeon commented that there was a large amount of "scar, soft tissue" around the joint, with some posterior osteophytes also noted. All of the impinging hard and soft tissue excised and a 42/+6 standard poly inserted. On reduction, shoulder joint demonstrated a greater range of motion, with no obvious instability or impingement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-08968 |
| MDR Report Key | 9878333 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 2019-05-20 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY FRANCE SAS 3003895575 |
| Manufacturer Street | 7 ALLEE IRENE JOLIOT-CURIE B.P. 256 |
| Manufacturer City | SAINT PRIEST CEDEX 69801 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DXTEND STAND PE CUP D42 +3MM |
| Generic Name | DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP |
| Product Code | KWS |
| Date Received | 2020-03-25 |
| Model Number | 130742203 |
| Catalog Number | 130742203 |
| Lot Number | 5341115 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY FRANCE SAS - 3003895575 |
| Manufacturer Address | 7 ALLEE IRENE JOLIOT-CURIE B.P. 256 SAINT PRIEST CEDEX 69801 FR 69801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-25 |