MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for UNKNOWN POLYETHYLENE COMPONENT UNK_SEL manufactured by Stryker Gmbh.
[185901014]
This complaint has been reported during a literature review performed by the post market surveillance group. The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. The device history record could not be reviewed because the affected lot number was not communicated. If any further information is provided, the investigation report will be updated. The reported device was manufactured and distributed by (b)(4) and implanted before stryker became the legal manufacturer. On april 1, 2015 stryker became the legal manufacturer of the star system and has taken the responsibility for the medical device reporting. Device disposition is unknown.
Patient Sequence No: 1, Text Type: N, H10
[185901016]
The manufacturer became aware of a literature from (b)(6), united states. The title of this report is? Intermediate-term experience with the star total ankle in the united states? Which is associated with the stryker? Scandinavian total ankle replacement (star)? System. Within that publication, post-operative complications/ adverse events were reported, which occurred from january 1999 to 2013. It was not possible to ascertain specific device details from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 76 complaints were initiated retrospectively for adverse events mentioned in the report. This product inquiry addresses coronal plane failure followed by revision arthroplasty. The report states:? The most common failure mode was progressive coronal plane deformity (n=8, 38%); however, no initial postoperative radiographs demonstrated coronal plan deformity greater than 4 degrees, and no threshold for tolerance of postoperative deformity was able to be determined. A general algorithm for noninfected failure management was used, which included revision and repositioning of metallic implants when possible.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2020-00918 |
| MDR Report Key | 9908259 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 1999-01-01 |
| Date Mfgr Received | 2020-03-09 |
| 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. ANNA JUSINSKI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER GMBH |
| Manufacturer Street | BOHNACKERWEG 1 POSTFACH |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN POLYETHYLENE COMPONENT |
| Generic Name | IMPLANT |
| Product Code | NTG |
| Date Received | 2020-03-31 |
| Catalog Number | UNK_SEL |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER GMBH |
| Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |