MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2017-11-21 for BONE SCREW 6.5X35 SELF-TAP N/A 00625006535 manufactured by Zimmer Manufacturing B.v..
[92728055]
(b)(4). Concomitant products: modular neck j 12/14 neck taper use with +0 heads only lot#61498558 item#00784803400, shell with cluster holes porous 60 mm o. D. Size mm for use with mm liners item#00875706001 lot#61615671, modular femoral stem press-fit plasma sprayed cementless size 10 item#00771301000 lot#61548895, bone scr 6. 5x20 selftap lot#61717199 item#00625006520, bone scr 6. 5x40 selftap lot#61649205 item#00625006540, metasul taper liner mm/40 item#00877001440 lot#2544861, metasul head 40, 12/14, size m /0 lot#245769 item#00877004002 the reported event is confirmed through operative notes received. No devices 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. Review of the complaint history determined that no further action is required. The compatibility check was reviewed and no issues were noted. The reported devices were in-vivo for 2 years 5 months post-implantation. The review of the initial op notes identified that the patient had good extension and no impingement. It also suggested that the hip did not dislocate at 60 degrees of external rotation. The review of the revision surgery notes suggested that the patient experienced pain. The notes also confirmed cloudy fluid in the hip joint as well as loosening of the stem with a significant amount of fibrotic material. 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 reports: 0001822565- 2017 -01265, 0001822565-2017-01269, 0001822565-2017-01270, 0002648920-2017-00709, 0002648920-2017-00710.
Patient Sequence No: 1, Text Type: N, H10
[92728056]
Legal counsel for patient reported that patient underwent a right hip revision approximately two years post-implantation due to infection. This report is based on allegations set forth in plaintiff? S complaint, and the allegations contained therein are unverified. Medical records indicated the patient was revised due to pain that began approximately three (3) months post-operatively and evidence of component loosening from radiographs. The operative report notes cloudy fluid, loosening of the femoral stem, and debridement of fibrotic material and nonviable tissue, all indicative of infection. All components were removed and replaced with cement spacers.
Patient Sequence No: 1, Text Type: D, B5
[132633447]
This follow-up report is being submitted to relay additional information. It was identified an internal software error produced and submitted an invalid device product code in the previous submissions related to this reporting. The device product code has been updated with no further changes. 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
[132633448]
No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002648920-2017-00708 |
| MDR Report Key | 7050261 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2017-11-21 |
| Date of Report | 2018-12-10 |
| Date of Event | 2013-12-17 |
| Date Mfgr Received | 2018-12-10 |
| Device Manufacturer Date | 2010-05-10 |
| Date Added to Maude | 2017-11-21 |
| 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 MANUFACTURING B.V. |
| Manufacturer Street | TURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1 |
| Manufacturer City | MERCEDITA PR 00715 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00715 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONE SCREW 6.5X35 SELF-TAP |
| Generic Name | PROSTHESIS, HIP |
| Product Code | NLF |
| Date Received | 2017-11-21 |
| Model Number | N/A |
| Catalog Number | 00625006535 |
| Lot Number | 61515065 |
| 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 MANUFACTURING B.V. |
| Manufacturer Address | TURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1 MERCEDITA PR 00715 US 00715 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-11-21 |