MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-09-12 for IMPACTOR FOR USE WITH 48 MM I.D. CUP N/A 00151603048 manufactured by Zimmer Biomet, Inc..
[120102451]
(b)(4). (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[120102452]
It was reported that the head of the impactor broke during a total hip arthroplasty procedure. No adverse event or harm to patient was reported. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[130030142]
This follow-up report is being submitted to relay additional information. Updated: it was identified an internal software error produced and submitted an invalid device product code in the previous submissions related to this reporting. The device product code has been updated with no further changes. 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
[130030143]
No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-04439 |
| MDR Report Key | 7871060 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-12 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-08-13 |
| Date Mfgr Received | 2018-12-11 |
| Date Added to Maude | 2018-09-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPACTOR FOR USE WITH 48 MM I.D. CUP |
| Generic Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Product Code | NLF |
| Date Received | 2018-09-12 |
| Model Number | N/A |
| Catalog Number | 00151603048 |
| Lot Number | 63571629 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-09-12 |