MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2015-01-28 for SYSTEM ONE BIPOLAR 6074-4722 manufactured by Stryker Orthopaedics-mahwah.
[5183827]
It was reported that bipolar cup was implanted in (b)(6) 2014. On (b)(6), bipolar cup separated from the inner head when the patient woke up. Revision surgery was performed on (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[12895128]
The subject device is not cleared for sale in the u. S. , but a similar device is commercially available in the u. S. A supplemental report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[31995007]
An event regarding disassociation involving a system one bipolar head was reported. The event was not confirmed method and results: device evaluation and results: a visual evaluation revealed that the 22. 2mm std v40 head and system one bipolar head were returned assembled together as they would have been in vivo during implantation. The inner v40 head was securely locked in place and could not be disassembled from the bipolar head without the aid of a disassembly tool to release the plastic retaining ring. Upon disassembly both components were found to be in excellent condition with no evidence of having been disassociated from one another after implantation. Medical records received and evaluation: not performed as no medical records were made available. Device history review: the reported device was manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been no other similar events reported for this manufacturing lot. Conclusions: the investigation concluded that the exact cause of the event could not be determined because further information such as pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation. It was also concluded that there is no indication the event is related to a manufacturing issue.
Patient Sequence No: 1, Text Type: N, H10
[31995008]
It was reported that bipolar cup was implanted in (b)(6) 2014. On (b)(6) bipolar cup separated from the inner head when the patient woke up. Revision surgery was performed on (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2015-00237 |
| MDR Report Key | 4460877 |
| Report Source | 00,05 |
| Date Received | 2015-01-28 |
| Date of Report | 2015-01-05 |
| Date of Event | 2015-01-02 |
| Date Mfgr Received | 2015-03-25 |
| Device Manufacturer Date | 2012-12-05 |
| Date Added to Maude | 2015-01-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. BEVERLY LIMA |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSTEM ONE BIPOLAR |
| Generic Name | IMPLANT |
| Product Code | KWB |
| Date Received | 2015-01-28 |
| Returned To Mfg | 2015-03-24 |
| Catalog Number | 6074-4722 |
| Lot Number | MLRPND |
| ID Number | STERILE LOT# MSLLT05A |
| Device Expiration Date | 2017-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Address | 325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-01-28 |