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 2018-02-14 for BIOSTOP G CEM RESTR 14MM 546314000 manufactured by Depuy Orthopaedic Inc, 1818910.
[100050127]
(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
[100050128]
Occurrence: cement restrictor breaking at the time of use. Details: on (b)(6) 2018, in the total hip arthroplasty surgery, using the 14 mm bio cement restrictor, it was broken. According to reports this is not the first time this happens. For this new event, he called attention to record what happened. It was identified that the instruments used today in the c-stem amt stem box, "is not compatible with the plug (cement restrictor)". We request clarification as to the instruments and techniques of use so that the problem does not happen again. Product available for analysis. Product information: (b)(4) and lot: 16f1306005.
Patient Sequence No: 1, Text Type: D, B5
[104610641]
.
Patient Sequence No: 1, Text Type: N, H10
[109260722]
Product complaint # pc-(b)(4). Investigation summaryexamination of the returned device confirmed the reported breakage. Based on the provided information and the preformed investigation, a definitive root cause cannot be determined. 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 | 1818910-2018-53416 |
| MDR Report Key | 7269835 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-14 |
| Date of Report | 2018-01-31 |
| Date of Event | 2018-01-23 |
| Date Mfgr Received | 2018-05-16 |
| Device Manufacturer Date | 2016-12-05 |
| Date Added to Maude | 2018-02-14 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 CMW |
| Manufacturer Street | CORNFORD RD |
| Manufacturer City | BLACKPOOL 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 14MM |
| Generic Name | DEPUY CMW RESORBABLE BIOMATERIALS : CEMENT CENTRALIZER/PLUG |
| Product Code | JDK |
| Date Received | 2018-02-14 |
| Returned To Mfg | 2018-03-16 |
| Catalog Number | 546314000 |
| Lot Number | 16F1306005 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-02-14 |