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 2020-03-30 for TAPERLOC XR FP TYPE1 PPS 5X130MM 1 NI 51-102050 manufactured by Zimmer Biomet, Inc..
[185903840]
(b)(4). Concomitant medical products: tprlc 133 fp type1 pps ho 5. 0 t1 cat# 51-101050 lot# 3692721, tprlc 133 fp type1 pps ho 5. 0 t1 cat# 51-101050 lot# 3590153, tprlc 133 t1 pps ho 17x154mm 4mm t1 cat# 51-104170 lot# 3706660, tprlc xr t1 pps 17x154mm mm t1 cat# 51-105170 lot# 3096162, tprlc 133 fp type1 pps ho 5. 0 t1 cat# 51-101050 lot# 2588486. (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: 0001825034-2020-01378, 0001825034-2020-01379, 0001825034-2020-01380, 0001825034-2020-01382, 0001825034-2020-01383.
Patient Sequence No: 1, Text Type: N, H10
[185903841]
It was reported that debris was identified within sterile packaging. There was no patient involvement. 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 | 0001825034-2020-01381 |
| MDR Report Key | 9900135 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-19 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2014-07-14 |
| 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 | TAPERLOC XR FP TYPE1 PPS 5X130MM 1 |
| Generic Name | PROSTHESIS, HIP |
| Product Code | LPH |
| Date Received | 2020-03-30 |
| Model Number | NI |
| Catalog Number | 51-102050 |
| Lot Number | 3368426 |
| 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 | 2020-03-30 |