MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-08-14 for SECUR-FIT HA PSL CUP/CLUSTR SHELL 52MM 2051-2052 manufactured by Stryker Orthopaedics-mahwah.
[22989682]
The information in this report was provided by stryker orthopaedics legal affairs. No additional information is available at this time due to ongoing litigation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[22989683]
It was reported as a result of a legal claim that allegedly on or about (b)(6) 1999, a stryker trident acetabular hip system ceramic on ceramic was implanted in the patient. On or about (b)(6) 2002, (b)(6) 2003, the patient allegedly suffered repeated dislocations of the left hip, lax gait. On or about (b)(6) 2003, the patient allegedly underwent revision surgery of the left trident system.
Patient Sequence No: 1, Text Type: D, B5
[30410045]
Conclusion: based on the provided information, the product reported in this investigation did not contribute to the event. The event indicates the hip dislocated, which occurs when the head dislocates from the liner. No allegations were made against any of the remaining devices. No further investigation is required at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Patient Sequence No: 1, Text Type: N, H10
[30410046]
It was reported as a result of a legal claim that allegedly on or about (b)(6) 1999, a stryker trident acetabular hip system ceramic on ceramic was implanted in the patient. On or about (b)(6) 2002, (b)(6) 2003, (b)(6) 2003 and (b)(6) 2003, the patient allegedly suffered repeated dislocations of the left hip, lax gait. On or about (b)(6) 2003, the patient allegedly underwent revision surgery of the left trident system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2015-02676 |
| MDR Report Key | 5003654 |
| Report Source | CONSUMER |
| Date Received | 2015-08-14 |
| Date of Report | 2015-07-17 |
| Date of Event | 1999-07-07 |
| Date Mfgr Received | 2015-09-18 |
| Device Manufacturer Date | 1999-05-04 |
| Date Added to Maude | 2015-08-14 |
| 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 | MR. WILLIAM HANNA |
| 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 | 2015-08-14 |
| Catalog Number | 2051-2052 |
| Lot Number | 40491401 |
| Device Expiration Date | 2004-05-31 |
| 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. Hospitalization; 2. Required No Informationntervention | 2015-08-14 |