MAUDE Adverse Event Report: BIOMET SPAIN, S.L. SPIDERCUP; PROSTHESIS, HIP

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This device is not manufactured by zimmer biomet in the united states; however, we are filing this report as zimmer biomet manufactures a similar device in the united states under 510k number k030055.Product not returned.

Event Description

"as part of the post market surveillance (pms) of the spidercup cup, the pms team has reviewed the survey completed by dr.(b)(6) of the (b)(6) hospital ((b)(6)).During the review of the survey several events were detected about the incidents that are mentioned: post-operative complications (deep infection> 3 months ""1 case for every 100 prostheses""; luxation ""due to erroneous orientation of the cup"") implant revision, cause by recurrent dislocation (""revision due to polyethylene wear and dislocation at 10 years, total 3 cases"")".

• Brand Name: SPIDERCUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET SPAIN, S.L.; calle islas baleares, #50; p.o. box 96; fuente del jarro, valencia 46988 ; SP 46988
• Manufacturer (Section G): BIOMET SPAIN, S.L.; calle islas baleares, #50; p.o. box 96; fuente del jarro, valencia 46988 ; SP 46988
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8211670
• MDR Text Key: 131890357
• Report Number: 0009610576-2019-00001
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 01/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1