MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor report with the FDA on 2020-03-12 for PERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) N/A 42522401012 manufactured by Zimmer Orthopaedic Mfg. Ltd..
[186529204]
(b)(4). Concomitant medical device: persona femur cemented posterior stabilized (ps), catalog #: 42500607002, lot #: 64121962. Nexgen all poly patella, catalog #: 00597206638, lot #: 64163556. Tibia cemented 5 degree stemmed right size g, catalog #: 42532007902, lot #: 64281805. Cemented persona/ve surf & instruments, catalog #: 9800674105, lot #: unknown. Patella reamer blade with pilot hole 51 mm diameter single use only, catalog #: 00597909551, lot #: 64418785. Customer has indicated that the product will not be returned because it remains implanted. Reported event was unable to be confirmed due to limited information received from the customer. Device was not returned. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.? 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. The event was initially reported on 0001822565-2019-04931. Multiple mdr: 3007963827-2020-00076, 0001822565-2019-04932.
Patient Sequence No: 1, Text Type: N, H10
[186529205]
It was reported that the patient underwent a knee arthroplasty. Subsequently, the patient alleges experiencing pain, stiffness and limited range of motion in knee. Further, the patient alleges uses a cane to ambulate and is scheduled to undergo a manipulation procedure. No revision procedure has been reported to date. Attempt for further information has been made, but no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007963827-2020-00075 |
| MDR Report Key | 9825963 |
| Report Source | CONSUMER,DISTRIBUTOR |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-09-24 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-04-18 |
| Date Added to Maude | 2020-03-12 |
| 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 ORTHOPAEDIC MFG. LTD. |
| Manufacturer Street | BUILDING NO 2 EAST PARK SHANNON INDUSTRIAL ESTATE |
| Manufacturer City | SHANNON, COUNTY CLARE |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | OIY |
| Date Received | 2020-03-12 |
| Model Number | N/A |
| Catalog Number | 42522401012 |
| Lot Number | 64363148 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER ORTHOPAEDIC MFG. LTD. |
| Manufacturer Address | BUILDING NO 2 EAST PARK SHANNON INDUSTRIAL ESTATE SHANNON, COUNTY CLARE EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-12 |