MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2018-10-29 for E-POLY 36MM +3 HIWALL LNR SZ23 N/A EP-108323 manufactured by Zimmer Biomet, Inc..
[125425384]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown. Concomitant medical products: item number: 650-1057, item name: cer bioloxd option hd 36mm, lot #: 854430; item number: 650-1964, item name: cer option type 1 tpr sleeve -6, lot #: 834070; item number: unknown, item name: unknown stem, lot #: unknown; item number: unknown, item name: unknown cup, lot #: unknown. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[125425385]
It was reported patient was revised due to liner fracture, pain and stiffness approximately 6 years post-implantation. The fractured liner caused the head to rub on the shell resulting in debris in the surrounding tissues. Attempts have been made and no additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-09879 |
| MDR Report Key | 8016868 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2018-10-29 |
| Date of Report | 2018-10-23 |
| Date of Event | 2018-09-12 |
| Date Mfgr Received | 2018-10-01 |
| Device Manufacturer Date | 2012-06-20 |
| Date Added to Maude | 2018-10-29 |
| 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 | E-POLY 36MM +3 HIWALL LNR SZ23 |
| Generic Name | PROSTHESIS, HIP |
| Product Code | MAY |
| Date Received | 2018-10-29 |
| Returned To Mfg | 2018-10-08 |
| Model Number | N/A |
| Catalog Number | EP-108323 |
| Lot Number | 278560 |
| Device Expiration Date | 2017-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-10-29 |