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 2018-08-28 for SEE H10 N/A 65771100600 manufactured by Zimmer Biomet, Inc..
[118523219]
(b)(4). Brand name: femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 6 standard offset. Concomitant medical product: item #00151504836, liner and shell with plastic barrier 36 mm i. D. 48 mm o. D. , lot# 62645668; item# 00877503602, biolox® delta, ceramic femoral head, m, ø 36/0, taper 12/14, lot# 2772607. Foreign source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports:...
Patient Sequence No: 1, Text Type: N, H10
[118523220]
It was reported that patient experienced moderate groin pain more than 2 years post implantation. Attempts were made to obtain additional information; however, none is available.
Patient Sequence No: 1, Text Type: D, B5
[130169714]
This follow-up report is being submitted to relay additional information. Updated: 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
[130169715]
No further information available.
Patient Sequence No: 1, Text Type: D, B5
[132226330]
This follow-up report is being submitted to relay additional information. Updated. Reported event was unable to be confirmed due to limited information received from the customer. Patient clinical history notes and mris were provided and the review identified the appearances are not concerning for infection or loosening. There is no periprosthetic osteolysis. No concerning features of active stress fracture. No periprosthetic soft tissue abnormality detected. " noted is a small amount of periprosthetic bone marrow edema in the posterosuperior weight bearing region of the acetabular cup and left femoral stem. Possibly a periprosthetic marrow stress response or stress shielding. Radiologist questions if patient recently increased low level activity as this could be the cause. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.
Patient Sequence No: 1, Text Type: N, H10
[132226331]
No further event information available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-04564 |
| MDR Report Key | 7824531 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-28 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-04-01 |
| Date Mfgr Received | 2018-12-11 |
| Device Manufacturer Date | 2014-07-31 |
| Date Added to Maude | 2018-08-28 |
| 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 | SEE H10 |
| Generic Name | PROSTHESIS HIP |
| Product Code | NLF |
| Date Received | 2018-08-28 |
| Model Number | N/A |
| Catalog Number | 65771100600 |
| Lot Number | 62746968 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-08-28 |