MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-01-03 for MAXERA CUP LINER AND SHELL WITH PLASTIC BARRIER N/A 00151505240 manufactured by Zimmer Inc.
[96330987]
(b)(4). Concomitant medical products: liner and shell with plastic barrier 40 mm i. D. 52 mm o. D. Do not remove ceramic liner do not reposition cup after final seating lot# 61752028 item#00151505240, the reported event could not be confirmed based on limited information received. No products were returned; therefore, the visual and dimensional inspections were not performed. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Components were reviewed for compatibility with no issues noted. Review of the complaint history determined that no further action is required. Radiograph review notes the acetabular cup lateral angle of inclination is mildly steep at approximately 48 degrees. An osteophytic bone growth superolateral acetabular roof projects into the soft tissues beyond the rim of the acetabular cup. This bony prominence may increase risk of overlying bursal fluid collection. Cortical irregularity at the lateral cortex of the left greater trochanter with small adjacent calcifications. These bone findings may increase risk of overlying bursal fluid collection. A definitive root cause cannot be determined with the information provided. No corrective actions, preventive actions, or field actions resulted after investigation of this event. 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. Multiple mdr reports were filed for this event, please see associated report: 0001822565-2017-01960.
Patient Sequence No: 1, Text Type: N, H10
[96330988]
It was reported that the patient experienced trochanteric bursitis approximately two and a half years post-implantation of a left total hip arthroplasty. The issue reportedly resolved following treatment with medication. X-ray reviews noted a slight cup angle inclination, osteophytic heterotopic acetabular bone growth projecting into soft tissues, and cortical irregularity and adjacent calcifications of the greater trochanter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2017-01959 |
| MDR Report Key | 7162943 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-01-03 |
| Date of Report | 2018-01-02 |
| Date of Event | 2016-08-18 |
| Date Mfgr Received | 2017-12-29 |
| Device Manufacturer Date | 2011-06-09 |
| Date Added to Maude | 2018-01-03 |
| 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 | MAXERA CUP LINER AND SHELL WITH PLASTIC BARRIER |
| Generic Name | PROSTHESIS, HIP |
| Product Code | NLF |
| Date Received | 2018-01-03 |
| Model Number | N/A |
| Catalog Number | 00151505240 |
| Lot Number | 61752028 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER INC |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-03 |