MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2015-05-14 for SECUR-FIT HA PSL CUP/CLUSTR SHELL 52MM 2051-2052 manufactured by Stryker Orthopaedics-mahwah.
[5782292]
It was reported that the patient's right hip revised due to pain. During the revision a loose cup was noted and revised.
Patient Sequence No: 1, Text Type: D, B5
[13425491]
It was noted that the device, medical records, and x-rays would not be provided due to hospital/surgeon policy. A supplemental report will be submitted upon completion of the investigation. Device not available.
Patient Sequence No: 1, Text Type: N, H10
[22531626]
An event regarding loosening involving a secur-fit psl cluster shell was reported. The event was not confirmed. Method & results: -device evaluation and results: could not be performed as no items associated with the event were returned or made available for evaluation. -medical records received and evaluation: no medical records were made available for evaluation. -device history review: review of the device history records indicates all devices accepted into final stock met specifications. -complaint history review: there has been no other event for this lot. Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and no medical information was provided. If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
Patient Sequence No: 1, Text Type: N, H10
[22531627]
It was reported that the patient's right hip revised due to pain. During the revision a loose cup was noted and revised.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2015-01540 |
| MDR Report Key | 4772547 |
| Report Source | 00,05 |
| Date Received | 2015-05-14 |
| Date of Report | 2015-04-17 |
| Date of Event | 2015-04-17 |
| Date Mfgr Received | 2015-05-18 |
| Device Manufacturer Date | 1998-08-27 |
| Date Added to Maude | 2015-05-14 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 2015-05-14 |
| Catalog Number | 2051-2052 |
| Lot Number | 35136202 |
| ID Number | STER LOT 9808T |
| Device Expiration Date | 2003-08-31 |
| 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 | 2015-05-14 |