MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-03-30 for LINER STANDARD 3.5 MM OFFSET 36 MM I.D. N/A 00630505036 manufactured by Zimmer Manufacturing B.v..
[187577672]
(b)(4). Reported event was unable to be confirmed due to limited information received from the customer. Device history record 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.
Patient Sequence No: 1, Text Type: N, H10
[187577673]
It was reported the patient underwent an initial total hip arthroplasty on an unknown date. Subsequently the patient has been indicated for a revision for unknown reasons. No revision has been reported to date. The sales rep was inquiring about implant identification. No further event information available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002648920-2020-00202 |
| MDR Report Key | 9900629 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2012-08-09 |
| Date Added to Maude | 2020-03-30 |
| 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 | 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 | LINER STANDARD 3.5 MM OFFSET 36 MM I.D. |
| Generic Name | PROSTHESIS, HIP |
| Product Code | LPH |
| Date Received | 2020-03-30 |
| Model Number | N/A |
| Catalog Number | 00630505036 |
| Lot Number | 62101590 |
| Device Expiration Date | 2017-07-31 |
| 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. Other | 2020-03-30 |