MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2020-03-27 for IT XLPE LINER NEUTRAL NI 00875101032 manufactured by Zimmer Manufacturing B.v..
[186302937]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation product location is unknown. Concomitant medical products: part # 00771101010/ femoral stem / lot #62645290, part # 00875705201/ shell / lot #62674908, part #00625006525/ bone screw / lot #62698746, part #00625006525/bone screw/ lot #62690221, part # 00877503201/biolox head/ lot # 2720466. Reported event was able to be confirmed by medical records review. The review confirmed instability, limb length discrepancy of more than 2cm, significant rheumatoid reactive tissues requiring extensive synovectomy, and previous dislocations resulting in a large tissue defect. Implants and tissue were sent to pathology however there no report is attached to review. From the revision surgery, final components were placed and limb lengths were equalized; there is good range of motion with no impingement and the wound was irrigated and closed in layers. Dhr was reviewed and no discrepancies relevant to the reported event were found. Review of complaint history found no additional related issues for this item and the reported part and lot combination. Root cause was unable to be determined. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[186302938]
It was reported that patient underwent hip revision surgery post implantation due to dislocation, instability, limb length discrepancy and tissue damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002648920-2020-00208 |
| MDR Report Key | 9888362 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-26 |
| Date of Event | 2018-10-29 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2014-05-02 |
| Date Added to Maude | 2020-03-27 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER MANUFACTURING B.V. |
| Manufacturer Street | TURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1 |
| Manufacturer City | MERCEDITA PR 00715 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00715 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IT XLPE LINER NEUTRAL |
| Generic Name | PROSTHESIS, HIP |
| Product Code | LZO |
| Date Received | 2020-03-27 |
| Model Number | NI |
| Catalog Number | 00875101032 |
| Lot Number | 62650655 |
| Device Expiration Date | 2019-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER MANUFACTURING B.V. |
| Manufacturer Address | TURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1 MERCEDITA PR 00715 US 00715 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-27 |