MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-07-30 for 22.2MM DIA COCR MOD HD -3MM NK N/A 163653 manufactured by Biomet Orthopedics.
[6636043]
It was reported that the patient underwent an initial total hip arthroplasty on (b)(6) 2015. Subsequently, the patient was revised on (b)(6) 2015 due to dislocation. During the revision, the locking ring popped off while impacting the liner into the acetabular cup. Another liner was utilized to complete the procedure and the modular head and acetabular cup were removed and replaced.
Patient Sequence No: 1, Text Type: D, B5
[14303394]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. There are warnings in the package insert that state that this type of event can occur: "dislocation and subluxation due to inadequate fixation and improper positioning. Muscle and fibrous tissue laxity can also contribute to these conditions. " this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-03447 & 03448).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2015-03447 |
| MDR Report Key | 4954487 |
| Report Source | 07 |
| Date Received | 2015-07-30 |
| Date of Report | 2015-07-09 |
| Date of Event | 2015-07-08 |
| Date Mfgr Received | 2015-07-09 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2015-07-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. MEGAN HAAS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726700 |
| 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 | 22.2MM DIA COCR MOD HD -3MM NK |
| Generic Name | PROSTHESIS, HIP |
| Product Code | KMC |
| Date Received | 2015-07-30 |
| Model Number | N/A |
| Catalog Number | 163653 |
| Lot Number | 990240 |
| ID Number | N/A |
| 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 | 2015-07-30 |