MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-08-27 for PINN CAN BONE SCREW 6.5MMX25MM 121725500 manufactured by Depuy Orthopaedic Inc, 1818910.
[118318745]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Reporter is an attorney.
Patient Sequence No: 1, Text Type: N, H10
[118318746]
New etq record created in order to update etq (legacy system) complaint number (b)(4). Reason for original complaint. - litigation alleges that patient has experienced pain, difficulty walking, loosening of the implant, popping in hip, numbness, tingling, and weakness. Doi: (b)(6) 2006; dor: none reported; (left side). Patient is a resident of (b)(6). Update: 11/19/2012 pfs was received from legal, medical records were received from legal, and part/lot information was identified. Records are available for further review. Update 2/17/16-pfs and medical records received. After review of the medical records for mdr reportability, a dor was provided. The revision operative note indicated pain and synovitis. There was no mention of loosening. The right hip ((b)(4)) was revised for elevated metal ion levels-no labs), so the stem will be added to this hip as well. The complaint was updated on: 3/4/2016. Update ad 24 april 2018: (b)(4) has been re-opened under (b)(4) due to receipt of ppf and sticker sheets. Ppf alleges loosening of cup and stem, metal wear and metallosis. Added cup 121722056, lot # at3f11000. Doi: (b)(6) 2006; dor: (b)(6) 2015; (left hip). (b)(4) - left hip. (b)(4) - right hip.
Patient Sequence No: 1, Text Type: D, B5
[123098164]
(b)(4). Investigation summary no device associated with this report was received for examination. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. 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
| Report Number | 1818910-2018-67779 |
| MDR Report Key | 7819233 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-08-27 |
| Date of Report | 2018-08-02 |
| Date of Event | 2015-06-09 |
| Date Mfgr Received | 2018-10-02 |
| Device Manufacturer Date | 2006-05-12 |
| Date Added to Maude | 2018-08-27 |
| 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 | MR. CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465820988 |
| Manufacturer Phone | 5743725905 |
| 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 | LXO |
| Date Received | 2018-08-27 |
| Catalog Number | 121725500 |
| Lot Number | AS7EW4000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDIC INC, 1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-27 |