MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2015-12-02 for CEMENTRALIZER 11.0 137620000 manufactured by Depuy Orthopaedics, Inc..
[32528115]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. (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
[32528116]
Primary surgery approximately 18 years ago. Patient recently developed pain and poly wear is evident on x-ray, patient was revised.
Patient Sequence No: 1, Text Type: D, B5
[36718935]
Primary surgery approximately 18 years ago. Patient recently developed pain and poly wear is evident on x-ray. Surgeon revised cup 16. 11, removed femoral head and inserted a new cup and head. The implants that were removed are: duraloc 300 sz 48mm cup, 22mm poly liner, size 11 elite plus stem and sz 22mm zirconia head. Patient outcome post surgery: unknown. (b)(6). Patient activity levels and relevant patient pre-existing conditions/ comorbidities: unknown. Pre op x-rays are available. No device associated with this report was received for examination. A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2015-36388 |
| MDR Report Key | 5261395 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2015-12-02 |
| Date of Report | 2015-11-16 |
| Date of Event | 2015-11-16 |
| Date Mfgr Received | 2016-01-22 |
| Device Manufacturer Date | 1998-12-14 |
| Date Added to Maude | 2015-12-02 |
| 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 | CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEMENTRALIZER 11.0 |
| Generic Name | HIP OTHER IMPLANT |
| Product Code | LTO |
| Date Received | 2015-12-02 |
| Catalog Number | 137620000 |
| Lot Number | S81J71 |
| Device Expiration Date | 2003-12-14 |
| 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. |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-02 |