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 2020-03-30 for BONE SCR SELF-TAP NI 00625006530 manufactured by Zimmer Biomet, Inc..
[186676893]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device remains implanted. Once the investigation has been completed a follow-up mdr will be submitted. Concomitant medical products: part # 010000856/ liner / lot #6475495, part # 51-104110/ stem / lot #6479649, part #110017102/ shell / lot #6428483, part # 650-1057/biolox head/ lot #2958839, part # 650-1065/trp sleve / lot #2950541. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020 -01320, 0001825034 -2020 -01321, 0001825034 -2020 -01322.
Patient Sequence No: 1, Text Type: N, H10
[186676894]
It was reported 3 months post implantation patient is allegedly experiencing hives, burning, swelling and pain into the thigh. Right hip remains implanted. The patient is going to have a metal allergy test conducted; however, no results have been provided to date. Attempts have been made and additional information on the reported event is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2020-01323 |
| MDR Report Key | 9899957 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-30 |
| 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 | BONE SCR SELF-TAP |
| Generic Name | PROSTHESIS, HIP |
| Product Code | LPH |
| Date Received | 2020-03-30 |
| Model Number | NI |
| Catalog Number | 00625006530 |
| Lot Number | 64356267 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Other | 2020-03-30 |