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 2020-02-27 for TPRLC XR MP T1 PPS 14X113MM 113MM T1 NI 51-145140 manufactured by Zimmer Biomet, Inc..
[189070877]
(b)(4). Tprlc 133 t1 pps ho 13x146mm 6mm t1, cat#51-104130 lot# 3799301, tprlc xr mp t1 pps 15x115mm 115mm t1, cat#51-145150 lot#3577454, tprlc xr mp t1 pps 16x117mm 117mm t1, cat# 51-145160 lot# 2920949, tprlc xr mp fp t1 pps 5x95mm t1, cat#51-149050 lot#3446162, tprlc xr mp t1 pps 16x117mm 117mm t1, cat#51-145160 lot#3011809. . 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: 0001825034-2020-00886, 0001825034-2020-00887, 0001825034-2020-00889, 0001825034-2020-00890 ,0001825034-2020-00891.
Patient Sequence No: 1, Text Type: N, H10
[189070878]
Hold for mrd 04/27/20. It was reported that debris was found within sterile packages. No patients were involved. 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 | 0001825034-2020-00888 |
| MDR Report Key | 9763336 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-02-27 |
| 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 | TPRLC XR MP T1 PPS 14X113MM 113MM T1 |
| Generic Name | PROSTHESIS, HIP |
| Product Code | OQG |
| Date Received | 2020-02-27 |
| Model Number | NI |
| Catalog Number | 51-145140 |
| Lot Number | 3150390 |
| 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 | 2020-02-27 |