MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-13 for REF XLPE 26 20 DEG 46-48 D 71333313 manufactured by Smith & Nephew, Inc..
[102301563]
Patient Sequence No: 1, Text Type: N, H10
[102301564]
It was reported that a revision surgery was performed due to the wearing.
Patient Sequence No: 1, Text Type: D, B5
[109823616]
The associated reflection acetabular liner was not returned for evaluation. Without the explant or the requested clinical information, the root cause of the wear cannot be concluded. The future impact to the patient beyond the revision cannot be determined. No further clinical/medical assessment is warranted at this time. Without the return of the actual product involved and no batch information available, our investigation cannot proceed. No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary. Should the device or additional information be received, the complaint will be reopened.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2018-00313 |
| MDR Report Key | 7336536 |
| Date Received | 2018-03-13 |
| Date of Report | 2018-04-17 |
| Date of Event | 2018-02-01 |
| Date Mfgr Received | 2018-02-16 |
| Date Added to Maude | 2018-03-13 |
| 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 MARKUS POETTKER |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | REF XLPE 26 20 DEG 46-48 D |
| Generic Name | TEST, ERYTHROCYTE SEDIMENTATION RATE |
| Product Code | JPH |
| Date Received | 2018-03-13 |
| Catalog Number | 71333313 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-13 |