MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,health professional,oth report with the FDA on 2015-06-01 for ACE SHELL-CLUST HOLE POR-58MM IMPLANT 186002-58 manufactured by Stryker Orthopaedics-mahwah.
[17332383]
Surgeon manually impacted the cup. Patient's hip was really tight and he struggled to reduce the hip. He noticed after reduction the cup had rotated. He then dislocated hip and removed cup. He manually impacted a second cup and used two screws. I spoke to him after case and he said it moved due to him trying to reduce the hip and it wasn't anything to do with the reaming or impacting.
Patient Sequence No: 1, Text Type: D, B5
[17524770]
Catalog number unknown at this time. Device description reported as unknown cup. Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[32707767]
Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been no other events reported for the reported manufacturing lot the event could not be confirmed nor the root cause of the reported event determined due to the minimal information received. No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics. If additional information becomes available, this investigation will be reopened.
Patient Sequence No: 1, Text Type: N, H10
[32707768]
Update as per sales rep: there was a 10 minute delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005985723-2015-00092 |
| MDR Report Key | 4808615 |
| Report Source | 00,05,HEALTH PROFESSIONAL,OTH |
| Date Received | 2015-06-01 |
| Date of Report | 2015-05-06 |
| Date of Event | 2015-05-06 |
| Date Mfgr Received | 2015-09-28 |
| Device Manufacturer Date | 2014-06-30 |
| Date Added to Maude | 2015-06-01 |
| 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 | 2015-06-01 |
| Catalog Number | 186002-58 |
| Lot Number | 030844-01 |
| Device Expiration Date | 2019-06-30 |
| 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. Required No Informationntervention | 2015-06-01 |