MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-07 for R3 0 DEGREE XLPE ACET LNR 40MM ID X 60OD 71338681 manufactured by Smith & Nephew, Inc..
[173949677]
It was reported that a revision surgery was performed due to insert dislocation. The removed poly was labeled as a 60, but when removing it read as a 58. Surgeon checked again to make sure the poly engaged in the cup and it did, so he opened up a 60 constrained r3 liner which also engaged in the readapt cup.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2020-00151 |
| MDR Report Key | 9558127 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-07 |
| Date of Report | 2020-02-17 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2019-08-26 |
| Date Added to Maude | 2020-01-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. SARAH FREESTONE |
| 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 | 3 |
| Brand Name | R3 0 DEGREE XLPE ACET LNR 40MM ID X 60OD |
| Generic Name | PRSTHSSHPSMICNSTRINDUNCMNTDMTALPLYMRPROUS |
| Product Code | MBL |
| Date Received | 2020-01-07 |
| Returned To Mfg | 2020-01-22 |
| Model Number | 71338681 |
| Catalog Number | 71338681 |
| Lot Number | 19HM21059 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-01-07 |