MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-04-06 for NATURAL KNEE ARTICULAR SURFACE 625001609 manufactured by Zimmer, Inc..
[71888127]
(b)(4). Concomitant medical products: it was reported that multiple devices were used during the procedure and may have caused or contributed to the adverse event. Zimmer biomet requested additional information on these devices from customer; however, a response has not yet been received. If this information becomes available, a supplemental mdr will be submitted. (b)(6). Customer has not indicated that the product will be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[71888128]
It was reported that a patient is to be revised due to wear of the polyethylene component. Attempts have been made for additional information and is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5
[74727281]
The follow-up report is being submitted to relay additional information. Investigation of this incident is currently ongoing. A follow-up/final report will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[77953375]
This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. Operative notes from the primary surgery state that the patient underwent left total knee arthroplasty due to "pangonarthrosis"; however, only the first page of the operative notes were returned. Per the current n-k system instructions for use, wear of the articular surface is a known potential risk of this procedure. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Review of the complaint history determined that no further action(s) is/are required. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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
| Report Number | 0001822565-2017-02114 |
| MDR Report Key | 6464425 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-04-06 |
| Date of Report | 2017-05-26 |
| Date Mfgr Received | 2017-05-18 |
| Date Added to Maude | 2017-04-06 |
| 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, INC. |
| Manufacturer Street | 1800 WEST CENTER STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46580 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NATURAL KNEE ARTICULAR SURFACE |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | HSH |
| Date Received | 2017-04-06 |
| Catalog Number | 625001609 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | 1800 WEST CENTER STREET WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-04-06 |