MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2013-02-15 for SECUR-FIT HA PSL CUP/CLUSTR SHELL 52MM 2051-2052 manufactured by Stryker Orthopaedics-mahwah.
[3329120]
It was reported that surgeon was doing a right hip revision - for dislocation. Surgeon said patient was walking on dislocated hip for approximately 3 months (12 weeks) and wore out a big chunk of the cup as a result of walking on the dislocation for such a long period of time. Cup and liner were replaced with another manufacturer's product, head was replaced with stryker.
Patient Sequence No: 1, Text Type: D, B5
[3541643]
It was reported that surgeon was doing a right hip revision - for dislocation. Surgeon said patient was walking on dislocated hip for approximately 3 months (12 weeks) and wore out a big chunk of the cup as a result of walking on the dislocation for such a long period of time. Cup and liner were replaced with another manufacturer's product, head was replaced with stryker.
Patient Sequence No: 1, Text Type: D, B5
[10462113]
The unknown liner was also listed in this report. It cannot be determined which, if any of these devices may have caused or contributed to the patient's dislocation. An evaluation of the device cannot be performed as the device was retained by the hospital and was not returned to the manufacturer. Additional information (including x-rays and medical records) has been requested. Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[10850944]
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies. The complaint history review indicated that there were no similar events for the reported lot. Patient x-rays and photographs of the explanted components were provided for review by a consulting clinician who indicated that there is no evidence that factors of faulty prosthetic design, manufacturing, or materials were responsible for this clinical situation. The exact root cause of the reported event could not be determined due to minimal information provided. Additional patient records such as patient demographics, operative reports, and/or past clinical history would be necessary in further evaluating this event and determining a root cause.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002249697-2013-00706 |
| MDR Report Key | 2964572 |
| Report Source | 00,05 |
| Date Received | 2013-02-15 |
| Date of Report | 2013-01-29 |
| Date of Event | 2013-01-29 |
| Date Mfgr Received | 2013-05-28 |
| Device Manufacturer Date | 1998-05-18 |
| Date Added to Maude | 2013-02-19 |
| 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 | MR. KEYLA NAVEDO |
| 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 | SECUR-FIT HA PSL CUP/CLUSTR SHELL 52MM |
| Generic Name | IMPLANT |
| Product Code | JDK |
| Date Received | 2013-02-15 |
| Catalog Number | 2051-2052 |
| Lot Number | RH3093 |
| ID Number | STERILE LOT# 9805I |
| Device Expiration Date | 2003-05-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2013-02-15 |