MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-08-15 for UNK CEMENT RESTRICTOR/PLUG manufactured by Depuy Orthopaedic Inc, 1818910.
[117256615]
(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
[117256616]
"femoral impaction allografting for significant bone loss in revision hip arthroplasty. " was reviewed on august 8, 2018. Study pertained to 45 hips (42 patients). Implanted between 2005-2011 all hips were implanted with: biostop g bone cement restrictor. Cmw 1 gentamicin. C-stem. Unknown depuy femoral head. Results/adverse events of the study: two intra-operative femoral canal perforations. One patient superficial non-infective hematoma (required surgical evacuation). One patient had a clinical significant pe with required medical treatment. Two cases of dislocation (1 managed with closed reduction and 1 managed with revision). Four cases of non-union of a greater trochanter. Four cases of leg length discrepancy. Twenty-eight cases of stem subsidence at 1 year post op (no revisions) subsidence ranged from 0. 1mm to 6mm).
Patient Sequence No: 1, Text Type: D, B5
[119544358]
Product complaint # ==> pc-(b)(4). Investigation summary ==> no information received with this individual complaint indicated that a broader investigation or corrective action was necessary. 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. 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 | 1818910-2018-66768 |
| MDR Report Key | 7786258 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-08-15 |
| Date of Report | 2018-02-20 |
| Date Mfgr Received | 2018-08-16 |
| Date Added to Maude | 2018-08-15 |
| 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 ORTHOPAEDIC INC, 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465820988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK CEMENT RESTRICTOR/PLUG |
| Generic Name | CEMENT ACCESSORY |
| Product Code | DZJ |
| Date Received | 2018-08-15 |
| Catalog Number | UNK CEMENT RESTRICTOR/PLUG |
| Lot Number | UNK |
| 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 ORTHOPAEDIC INC, 1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-15 |