MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-01-02 for PINN CAN BONE SCREW 6.5MMX25MM 121725500 manufactured by Depuy International Ltd. 8010379.
[131770665]
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. (b)(4). Attorney.
Patient Sequence No: 1, Text Type: N, H10
[131770666]
Patient was revised to address thigh pain. The stem was stable, but there was no bony in-growth. Update 7/18/12 - litigation papers received. It alleges that the patient suffers from pain, discomfort, mobility issues, implant loosening and wear. During the revision, the pinnacle liner remained intact, while the head was replaced with srom. Update ad 25 jun 2018: receipt of ppf and medical record. Ppf alleges abductor muscle repair, metallosis, elevated metal ions, loosening of the cup and stem. After review of medical record for mdr reportability, patient was revised to address "persisitent" pain and loosening of the femoral component. Added cup and screws due to alleged loosening.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2019-79472 |
| MDR Report Key | 8207875 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2019-01-02 |
| Date of Report | 2018-12-06 |
| Date of Event | 2009-08-18 |
| Date Mfgr Received | 2019-09-18 |
| Device Manufacturer Date | 2007-04-25 |
| Date Added to Maude | 2019-01-02 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY RAYNHAM |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PINN CAN BONE SCREW 6.5MMX25MM |
| Generic Name | BONE SCREWS AND PINS : SCREWS |
| Product Code | NDJ |
| Date Received | 2019-01-02 |
| Catalog Number | 121725500 |
| Lot Number | BP8BR4000 |
| 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 INTERNATIONAL LTD. 8010379 |
| Manufacturer Address | ST. ANTHONY'S RD LEEDS LS118 DT UK LS11 8 DT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-02 |