MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-31 for V40 COCR LFIT HEAD 40MM/+4 6260-9-240 manufactured by Stryker Orthopaedics-mahwah.
[186011362]
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the lot referenced. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation. Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a capa. The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011. The root cause analysis identified a process related anomaly as to the affected sizes and lots. The affected product has all been implanted and/or expired. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[186011363]
It was reported that the patient's right hip was revised due to disassociation of the head from the stem. Intra-operatively, moderate black tissue was observed. The patient's stem, head and liner were revised to a restoration modular stem construct with a ceramic head and poly liner. Rep confirmed there are no allegations against the revised liner, and confirmed that no further information will be available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2020-00644 |
| MDR Report Key | 9904226 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2008-07-10 |
| Date Added to Maude | 2020-03-31 |
| 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. COLLIN NEITZEL |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2249697-08/29/2016-007R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | V40 COCR LFIT HEAD 40MM/+4 |
| Generic Name | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED |
| Product Code | JDI |
| Date Received | 2020-03-31 |
| Model Number | 6260-9-240 |
| Catalog Number | 6260-9-240 |
| Lot Number | K92MKE |
| Device Expiration Date | 2013-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-31 |