MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-01-03 for MONOBLOCK INSERTER HANDLE N/A 110024780 manufactured by Zimmer Biomet, Inc..
[174412223]
(b)(4). 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.
Patient Sequence No: 1, Text Type: N, H10
[174412224]
It was reported the surgeon was implanting the arcos one-piece stem into the right hip, the threaded tip of the inserter hand broke off into the prosthesis about a third of the way down of being fully implanted. Surgeon proceeded to try to remove the tip from the stem but couldn't because all that was exposed in the insertion hole was a flat smooth surface. About 2 mm of the tip broke off. Since it was impossible to remove the broken instrument, the surgeon decided to leave it embedded in the implant since it was safely stuck in the stem. 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 | 0001825034-2020-00018 |
| MDR Report Key | 9544781 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-01-03 |
| Date of Report | 2020-01-02 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2019-12-13 |
| Date Added to Maude | 2020-01-03 |
| 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 | MONOBLOCK INSERTER HANDLE |
| Generic Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Product Code | HXC |
| Date Received | 2020-01-03 |
| Model Number | N/A |
| Catalog Number | 110024780 |
| Lot Number | 744190 |
| 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 | 1. Other | 2020-01-03 |