MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM - REVISION TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem Joint Dislocation (2374)

Event Date 02/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number :00801803203, lot number:63975961, brand name : cocr heads; catalog number :00710505632, lot number:63656052, brand name : xlpe liners; catalog number :00994301635, lot number:63250156, brand name : zmr - bodies.Unknown stryker cup multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00185, 0001822565-2019-01091, 0001822565-2019-01093.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned for evaluation.

Event Description

It was reported that the patient was revised one (1) week post-implantation due to recurrent dislocation.The surgeon believed the stem was anteverted and possibly contributing to the dislocations.All products were removed and replaced.Attempts have been made and additional information on the reported event is unavailable.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of xrays which indicated dislocation of the left hip.Xray also noted a long-stem femoral component was present with cerclage wire fixation and a periprosthetic fracture device history record (dhr) was reviewed and no discrepancies were found.The zimmer biomet hip components were used in conjunction with competitor hip component.Zimmer-biomet has not assessed or confirmed the compatibility of these combinations of devices, and these would be considered off-label usages of these devices.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.

• Brand Name: FEMORAL STEM - REVISION TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8416038
• MDR Text Key: 138644388
• Report Number: 0001822565-2019-01092
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K992667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00998201718
• Device Lot Number: 63250156
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 03/13/2019
• Supplement Dates Manufacturer Received: 09/12/2019
• Supplement Dates FDA Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 91 YR