MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2017-03-23 for UNKNOWN MALLORY-HEAD CUP N/A manufactured by Biomet Orthopedics.
[70638966]
(b)(4). Medical product - unknown femoral head, unknown hexloc liner, unknown ringloc liner, unknown bi-metric stem, all catalog#'s: ni, all lot#'s: ni. Event occurred in (b)(6). The following could not be completed with the limited information provided. Date of event - ni, expiration date - ni, date implanted - ni, date explanted - ni, manufacture date - ni. It has been indicated that the product will not be returned to zimmer biomet, as its location is unknown. Reported event was unable to be confirmed due to limited information received from the customer. Dhr review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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. Palom? Ki, a. , lempainen, l. , matilainen, m. , eskelinen, a. , remes, v. , virolainen, p. , m? Kel? , k. T. (2017). Survival of uncemented cups from a single manufacturer implanted from 1985 to 2103: finnish arthroplasty register data. Archives of orthopaedic and trauma surgery, 137, 311-320.
Patient Sequence No: 1, Text Type: N, H10
[70638967]
It was reported in a journal article that 12 patients underwent revision procedures due to implant fracture. Attempts have been made and additional information on the reported event is unavailable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-01883 |
| MDR Report Key | 6427265 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2017-03-23 |
| Date of Report | 2017-03-22 |
| Date Mfgr Received | 2017-02-21 |
| Date Added to Maude | 2017-03-23 |
| 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 | BIOMET ORTHOPEDICS |
| 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 | UNKNOWN MALLORY-HEAD CUP |
| Generic Name | PROSTHESIS, HIP |
| Product Code | KMC |
| Date Received | 2017-03-23 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-03-23 |