MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-18 for CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 10 MM THICKNESS N/A 42527900200 manufactured by Zimmer Biomet, Inc..
[183920390]
(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Event occurred in (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001822565? 2020 - 00964, 0001822565? 2020 - 00965, 0001822565? 2020 - 00966, 0001822565? 2020 - 00967, 0001822565? 2020 - 00968, 0001822565? 2020 - 00969, 0001822565? 2020 - 00970, 0001822565? 2020 - 00971, 0001822565? 2020 - 00972, 0001822565? 2020 - 00973, 0001822565? 2020 - 00974, 0001822565? 2020 - 00975, 0001822565? 2020 - 00976, 0001822565? 2020 - 00977, 0001822565? 2020 - 00978, 0001822565? 2020 - 00979, 0001822565? 2020 - 00980, 0001822565? 2020 - 00981, 0001822565? 2020 - 00982, 0001822565? 2020 - 00983.
Patient Sequence No: 1, Text Type: N, H10
[183920391]
It was reported that the device was missing one or more ball bearings that appear to be detaching during or after the sterilization process. There was no patient involvement. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-00964 |
| MDR Report Key | 9847828 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2014-05-02 |
| Date Added to Maude | 2020-03-18 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 10 MM THICKNESS |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBH |
| Date Received | 2020-03-18 |
| Model Number | N/A |
| Catalog Number | 42527900200 |
| Lot Number | 62702757 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-18 |