MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,health p report with the FDA on 2017-12-10 for 22.2MM DIA COCR MOD HD STD NK N/A 163651 manufactured by Zimmer Biomet, Inc..
[94351759]
This follow-up report is being submitted to relay additional information. Concomitant medical products: cocr head pn: 163651 ln: 477330. Reported event was unable to be confirmed. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Review of complaint history determined that no further action is required as no trends were identified. 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
[94351760]
It was reported that patient has undergone three hip revision surgeries. Patient continues experience click sounds and pain. Attempts have been made to obtain additional information; however, no information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
[114846064]
This follow-up report is being submitted to relay additional information.
Patient Sequence No: 1, Text Type: N, H10
[114846065]
It was reported patient is experiencing a clicking sound and pain post revision. Tests showed patient had fluid which was drained. Patient also reported her hip caught and she fell down. Patient is also experiencing numbness in the toes. Revision is being planned yet none has been reported to date. No further information has been made available at this time.
Patient Sequence No: 1, Text Type: D, B5
[119059887]
This follow-up report is being submitted to relay additional information. 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
[130674502]
This report is being submitted to relay additional information. The following sections have been updated. Review of the additional information received indicated no change to previously submitted investigation results.
Patient Sequence No: 1, Text Type: N, H10
[130674503]
No further event information available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-11037 |
| MDR Report Key | 7103072 |
| Report Source | CONSUMER,DISTRIBUTOR,HEALTH P |
| Date Received | 2017-12-10 |
| Date of Report | 2018-12-14 |
| Date of Event | 2018-03-27 |
| Date Mfgr Received | 2018-12-10 |
| Device Manufacturer Date | 2015-10-06 |
| Date Added to Maude | 2017-12-10 |
| 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 BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 22.2MM DIA COCR MOD HD STD NK |
| Generic Name | PROSTHESIS, HIP |
| Product Code | KMC |
| Date Received | 2017-12-10 |
| Model Number | N/A |
| Catalog Number | 163651 |
| Lot Number | 477330 |
| ID Number | (01) 00880304256446 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-12-10 |