MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,company representative report with the FDA on 2015-05-12 for ACE SHELL-CLUST HOLE POR-58MM IMPLANT 186002-58 manufactured by Stryker Orthopaedics-mahwah.
[5785677]
Surgeon reamed and impacted. Needed more fixation/screws. Converted to stryker multi-hole. The only issue was poor fixation which requires additional screws.
Patient Sequence No: 1, Text Type: D, B5
[13427016]
Catalog number unknown at this time. Device description reported as unknown 58 mako cup. Additional information was requested and if it becomes available will be submitted in a supplemental report. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[31404815]
The event reported does not represent a complaint. It was reported the surgeon felt better fixation could be achieved with more than 3 screws. As the reported product only has 3 screw holes, the surgeon elected to use a different cup. No device deficiencies were reported. No further investigation is required at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened. Product surveillance will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[31404817]
Surgeon reamed and impacted. Needed more fixation/screws. Converted to stryker multi-hole. The only issue was poor fixation which requires additional screws.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005985723-2015-00072 |
| MDR Report Key | 4765099 |
| Report Source | 07,COMPANY REPRESENTATIVE |
| Date Received | 2015-05-12 |
| Date of Report | 2015-04-14 |
| Date of Event | 2015-04-10 |
| Date Mfgr Received | 2015-09-30 |
| Date Added to Maude | 2015-06-09 |
| 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 | MS. BEVERLY LIMA |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | MAKO SURGICAL CORP. |
| Manufacturer Street | 2555 DAVIE ROAD |
| Manufacturer City | FORT LAUDERDALE FL 33317 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33317 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACE SHELL-CLUST HOLE POR-58MM IMPLANT |
| Generic Name | HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE |
| Product Code | OQI |
| Date Received | 2015-05-12 |
| Catalog Number | 186002-58 |
| Lot Number | 030987-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2015-05-12 |