MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2020-03-04 for SHELL POROUS WITH CLUSTER HOLES 52 MM N/A 00620205222 manufactured by Zimmer Biomet, Inc..
[181930264]
(b)(4). Concomitant medical products: zimmer head, cat# 00801803602, lot# 63135590. Zimmer liner, cat# 00630505036, lot# 61049361. Zimmer stem, cat# 00771300700, lot# 60825861. Zimmer neck, cat# 00784803300, lot# 62124936. Reported event was confirmed with medical records provided. Review of the available records identified the following: post revision, the patient was stuck with a 'stick' in his left thigh and underwent a irrigation and debridement procedure. There was superficial penetration - a 'stick' was embedded in the anterior thigh. The patient developed swelling and erythema. Seroma like fluid was present in the joint space and osteolysis was observed around the acetabular component. Soft tissue necrosis was present. Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event. Root cause was unable to be determined. 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: 0002648920-2020-00149, 000264892-2020-00021.
Patient Sequence No: 1, Text Type: N, H10
[181930265]
It was reported patient underwent hip revision approximately 6 months after prior revision due to osteolysis and necrosis. During revision, fluid, osteolysis, necrosis, and metallosis were noted. Liner and head were removed and replaced. No further event information available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-00769 |
| MDR Report Key | 9785270 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2016-05-18 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2008-11-26 |
| Date Added to Maude | 2020-03-04 |
| 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 | SHELL POROUS WITH CLUSTER HOLES 52 MM |
| Generic Name | PROSTHESIS, HIP |
| Product Code | KWZ |
| Date Received | 2020-03-04 |
| Model Number | N/A |
| Catalog Number | 00620205222 |
| Lot Number | 61132699 |
| Device Expiration Date | 2018-11-30 |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-04 |