MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-11-02 for BIOSTOP G CEM RESTR 16MM 546316000 manufactured by Depuy Orthopaedics Inc Us.
[30107046]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[30107047]
New etq record created in order to update etq (legal system) complaint number (b)(4). Reason for original complaint: litigation papers allege the patient was revised due to implant failure. Update rec'd 4/21/15- amended litigation papers received. Original litigation indicated that the patient was implanted with asr; however, amended litigation alleges that the patient was implanted with pinnacle. The products have been updated and follow-ups created. In addition to what was previously reported, litigation alleges the patient suffers from damage to her hip joints and body. Litigation identified that this complaint is for the right hip. Update 10/9/15 medical records received. After review of the medical records the patient had a poly/metal construct, not metal/metal. All implants are now being reported, as they cannot be excluded as the cause of pain. No revision operative note has been provided. Litigation papers allege the patient had pain and a lump and that "the top of implant needs replaced". At the time of this review there was no mention of lumps or need for revision in the medical documents provided. The complaint was updated on:10/30/2015.
Patient Sequence No: 1, Text Type: D, B5
[31499616]
Examination of the reported devices was not possible as they were not returned. A search of the complaints databases identified one other report against the femoral head and no other reports against the remaining product/product lot code combinations. The investigation can draw no conclusions with the information made available. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. 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. Corrective action was not indicated. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2015-34251 |
| MDR Report Key | 5195138 |
| Report Source | CONSUMER |
| Date Received | 2015-11-02 |
| Date of Report | 2015-10-09 |
| Date Mfgr Received | 2015-11-02 |
| Device Manufacturer Date | 2009-04-16 |
| Date Added to Maude | 2015-11-02 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY CMW 9610921 |
| Manufacturer Street | CORNFORD RD |
| Manufacturer City | BLACKPOOL, LANCASHIRE FY4 4QQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | FY4 4QQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOSTOP G CEM RESTR 16MM |
| Generic Name | CEMENT / CEMENT ACCESSORY |
| Product Code | JDK |
| Date Received | 2015-11-02 |
| Catalog Number | 546316000 |
| Lot Number | 08E1302 |
| Device Expiration Date | 2011-07-31 |
| 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 ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2015-11-02 |