MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-11 for R3 0 HOLE HA CTD ACET SHELL 50MM 71332250 manufactured by Smith & Nephew, Inc..
[183106223]
It was reported that during surgery the cup was impacted. The liner was placed and it sat down to where it should normally sit and was impacted without issue. The surgeon then went on to prepare the stem in his usual manner. When the trial reduction was done the r3 cup spun out of position. The surgeon said that the patient's acetabulum was very poor bone and the repeated attempts to impact the liner in the cup had made the bone too soft to hold the shell properly. He asked for a 3 hole r3 50mm cup to be opened and this was successfully implanted with 2 x 40mm screws. The same liner was removed from the no hole cup and successfully impacted into the 3 hole cup.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2020-00838 |
| MDR Report Key | 9821172 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2019-03-18 |
| Date Mfgr Received | 2019-03-18 |
| Device Manufacturer Date | 2015-04-27 |
| Date Added to Maude | 2020-03-11 |
| 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 Phone | 0447940038 |
| 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 HOLE HA CTD ACET SHELL 50MM |
| Generic Name | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS |
| Product Code | MBL |
| Date Received | 2020-03-11 |
| Catalog Number | 71332250 |
| Lot Number | 15DM17555 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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. Required No Informationntervention | 2020-03-11 |