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 2020-03-02 for TAPERLOC COMPLETE PPS TYPE 1 NI 51-105160 manufactured by Zimmer Biomet, Inc..
[188873398]
(b)(4). Concomitant medical products : tprlc xr t1 pps 10x140mm mm t1, cat#51-105100 lot#3604842, tprlc 133 t1 pps ho 16x152mm 2mm t1 ,cat#51-104160 lot#2441503, tprlc xr mp t1 pps 16x117mm 117mm t1, cat#51-145160 lot#3011809, tprlc 133 t1 pps so 17x154mm t1, cat#51-103170 lot#3677525, tprlc 133 fp type1 pps so 6. 0 ,cat#51-100060 lot#3482586. Foreign country: (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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020 -00952 0001825034 - 2020-00954, 0001825034 - 2020-00955, 0001825034-2020- 00956, 0001825034-2020- 00957.
Patient Sequence No: 1, Text Type: N, H10
[188873399]
Hold for michaelit was reported that while the distributorship was reviewing the inventory, they identified debris within the sterile packaging. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 0001825034-2020-00953 |
MDR Report Key | 9773899 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2020-03-02 |
Date of Report | 2020-02-28 |
Date of Event | 2020-02-18 |
Date Mfgr Received | 2020-02-18 |
Device Manufacturer Date | 2013-01-30 |
Date Added to Maude | 2020-03-02 |
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 | TAPERLOC COMPLETE PPS TYPE 1 |
Generic Name | PROSTHESIS, HIP |
Product Code | KWZ |
Date Received | 2020-03-02 |
Model Number | NI |
Catalog Number | 51-105160 |
Lot Number | 2955987 |
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 | 2020-03-02 |