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 2019-12-08 for TAPERLOC MICROP LAT FMRL 9.0MM N/A 15-103203 manufactured by Zimmer Biomet, Inc..
[169796006]
(b)(4). Concomitant medical products: item# 11-363662 36mm cocr mod hd std lot# 618180, item# ep-108323 e-poly 36mm +3 hiwall lnr sz23 lot# 619330, item# pt-116052 regen/rnglc+ ltd 52mm sz 23 lot# 480870. (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. 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 - 2019 - 05488.
Patient Sequence No: 1, Text Type: N, H10
[169796007]
It was reported a patient underwent right hip arthroplasty. Subsequently, the patient was revised approximately 5 years post initial implantation due to pain, heterotopic ossification, pseudocapsule, periprosthetic fracture, poor bone quality, and implant (cup) malposition. Attempts were made to obtain additional information; however, none was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-05487 |
| MDR Report Key | 9435207 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2019-12-08 |
| Date of Report | 2020-03-13 |
| Date of Event | 2019-04-26 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2008-09-01 |
| Date Added to Maude | 2019-12-08 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAPERLOC MICROP LAT FMRL 9.0MM |
| Generic Name | PROSTHESIS, HIP |
| Product Code | PBI |
| Date Received | 2019-12-08 |
| Model Number | N/A |
| Catalog Number | 15-103203 |
| Lot Number | 050760 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Hospitalization; 2. Required No Informationntervention | 2019-12-08 |