MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-26 for UNKNOWN ACETABULAR SHELL UNK_REC manufactured by Stryker Orthopaedics-mahwah.
[36886552]
An evaluation of the device cannot be performed as the device was not returned to the manufacturer. Additional information has been requested and if received, will be provided in the supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[36886553]
Acetabular components revised to competitor product in 2011.
Patient Sequence No: 1, Text Type: D, B5
[40740159]
An event regarding loosening involving an unknown shell was reported. The event was confirmed. Method and results: device evaluation and results: visual, dimensional and functional inspection was not performed as no devices were returned. Medical records received and evaluation: a review of the provided information by a clinical consultant concluded that : for the failure in 2011 with cup revision there is no information available to even suggest a failure mode although cup loosening as such was confirmed. Procedure related factors are usually involved in such problems where device-related matters hardly ever play a role. X-rays would be required to help solve this problem. Also in this case patient? S morbid obesity may have been an additional risk factor conclusions: the exact cause of the event could not be determined because insufficient information was provided. Further information such as return of device, xrays, patient history & follow-up notes are needed to investigate this event further. If additional information and/or device become available, this investigation will be reopened.
Patient Sequence No: 1, Text Type: N, H10
[40740160]
Acetabular components revised to competitor product in 2011.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2016-00194 |
| MDR Report Key | 5391757 |
| Date Received | 2016-01-26 |
| Date of Report | 2015-12-30 |
| Date of Event | 2011-01-01 |
| Date Mfgr Received | 2016-02-26 |
| Date Added to Maude | 2016-01-26 |
| 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 | MRS. KEYLA COLON |
| 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 | UNKNOWN ACETABULAR SHELL |
| Generic Name | HIP IMPLANT |
| Product Code | KWB |
| Date Received | 2016-01-26 |
| Catalog Number | UNK_REC |
| Lot Number | UNKNOWN |
| 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 | 2016-01-26 |