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 2018-02-07 for BIOMET E1 POLY LINER N/A EP-108323 manufactured by Zimmer Biomet, Inc..
[99297268]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for evaluation, due to the implant remains implanted. The evaluation is in process. Once the evaluation has been completed, a follow-up mdr will be submitted. Maude report mw5073429. Product remains implanted. 16-104150 ringloc+ shell lot # 847500. Multiple mdr reports were filed for this event. Please see associated reports: 0001825034-2018-00376, 00377. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[99297269]
It was reported a patient is experiencing worsening pain, a limp, ambulation difficulties, muscle spasms, muscle damage, and numbness from hip down to toes for the past 2 years. Patient also alleges that the hip "tried to dislocate" on two occasions. Patient reports being prescribed percocet for pain.
Patient Sequence No: 1, Text Type: D, B5
[119060288]
This follow-up report is being submitted to relay additional information. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-01649-1, 0001825034-2018-00377-2, 0001825034-2018-00376-2.
Patient Sequence No: 1, Text Type: N, H10
[119060289]
It was reported that a patient started experiencing pain 4 years post implantation. The patient is experiencing worsening pain, a limp, ambulation difficulties, muscle spasms, muscle damage, and numbness from hip down to toes for the past 2 years. Patient also alleges that the hip "tried to dislocate" on two occasions. Patient reports being prescribed percocet for pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-00377 |
| MDR Report Key | 7249206 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-02-07 |
| Date of Report | 2018-03-06 |
| Date of Event | 2011-02-13 |
| Date Mfgr Received | 2018-03-01 |
| Device Manufacturer Date | 2010-02-01 |
| Date Added to Maude | 2018-02-07 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | BIOMET E1 POLY LINER |
| Generic Name | HIP PROSTHESIS |
| Product Code | MAY |
| Date Received | 2018-02-07 |
| Model Number | N/A |
| Catalog Number | EP-108323 |
| Lot Number | 301360 |
| ID Number | (01) 00880304469006 |
| Device Expiration Date | 2015-02-28 |
| Operator | PHYSICIAN |
| 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. Other | 2018-02-07 |