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 2019-11-27 for G7 PPS LTD ACET SHELL 52E NI 010000663 manufactured by Zimmer Biomet, Inc..
[168270124]
(b)(4). Concomitant medical products: ep-200148- act artic e1 hip brg- 017610, 11-301322-arcos con-474370, 11-301000- mod femoral prox-810870, 110024463- g7 dual mobility liner- 690310, 11-300815- arcos 15x150mm spl tpr- 351720, 00625006535 bone screw 6. 5x35 self-tap 63651675, 12-115110- cer bioloxd mod- 2912205, 00223200418- cable cerclage cable- 63989795. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 05335, 0001825034 - 2019 - 05336, 0001825034 - 2019 - 05337, 0001825034 - 2019 - 05339, 0001825034 - 2019 - 05341. Customer has indicated that the product will not be returned to zimmer biomet for investigation, requested but not returned by hospital. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Requested but not returned by hospital.
Patient Sequence No: 1, Text Type: N, H10
[168270125]
It was reported that patient underwent right hip revision. Subsequently, patient underwent third revision approximately one and half years post initial implantation for infection. All devices were removed and replaced with cement spacers. Sales rep indicates no additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-05338 |
| MDR Report Key | 9384074 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-11-27 |
| Date of Report | 2019-11-25 |
| Date of Event | 2019-11-05 |
| Date Mfgr Received | 2019-11-05 |
| Date Added to Maude | 2019-11-27 |
| 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 | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | G7 PPS LTD ACET SHELL 52E |
| Generic Name | PROSTHESIS, HIP |
| Product Code | PBI |
| Date Received | 2019-11-27 |
| Model Number | NI |
| Catalog Number | 010000663 |
| Lot Number | 6289244 |
| 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 | 2019-11-27 |