MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2018-07-02 for 22.2MM DIA COCR MOD HD STD NK N/A 163651 manufactured by Zimmer Biomet, Inc..
[112993572]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Legal notification.
Patient Sequence No: 1, Text Type: N, H10
[112993573]
It was reported that patient underwent a revision surgery approximately 3. 5 years post implantation due to disassociation of the femoral head from a competitor poly femoral head, as well as dislocation of competitor devices. During the previous surgery, the surgeon cemented competitor cup into biomet cup with competitor metal liner and competitor dual mobility poly head. Op notes indicate the back of the prosthesis had gone through the fascia. There was no soft tissue attachment to the greater trochanter posteriorly, superiorly, and very sparsely anteriorly; abductor deficient; essentially naked capsule.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-04379 |
| MDR Report Key | 7656920 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2018-07-02 |
| Date of Report | 2018-08-21 |
| Date of Event | 2017-08-19 |
| Date Mfgr Received | 2018-08-15 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2018-07-02 |
| 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 | 22.2MM DIA COCR MOD HD STD NK |
| Generic Name | HIP PROSTHESIS |
| Product Code | KMC |
| Date Received | 2018-07-02 |
| Model Number | N/A |
| Catalog Number | 163651 |
| Lot Number | 990220 |
| ID Number | N/A |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-07-02 |