MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. MULTIPOLAR BIPLOAR LINER 28 MM I.D. FOR USE WITH 44/45/46 MM O.D. SHELLS; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Reaction (2414); Blood Loss (2597)

Event Date 01/11/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00500104428, pe bipolar liner, 60722508; 437644067, durasul liner, 60778565; 00620207220, trabe metal mod cup multi-hole, 60592636; unknown, smith and nephew head 28 mm x 16 mm neck, unknown; unknown, optiflex stem, unknown; 00625006515, bone screw self-tapping 6.5 mm dia.15 mm length, 60713479; 00625006515, bone screw self-tapping 6.5 mm dia.15 mm length, 60773963; 00625006520, bone screw self-tapping 6.5 mm dia.20 mm length, 60959537; 00625006535, bone screw self-tapping 6.5 mm dia.35 mm length, 60965163; 00625006540, bone screw self-tapping 6.5 mm dia.40 mm length, 60838382; 00625006550, bone screw self-tapping 6.5 mm dia.50 mm length, 60990156; 00625006560, bone screw self-tapping 6.5 mm dia.60 mm length, 60732348.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.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2018 - 00372, 0001822565 - 2018 - 01512, 0001822565 - 2018 - 01513.Product location unknown.

Event Description

It was reported that a patient underwent a right hip revision procedure.During the procedure, the patient experienced an estimated blood loss of 1300 ml.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

The following report is submitted to include the corrections and additional information received.This report has no change in the previously reported investigation results.It was reported that the surgeon used a smith and nephew head with a zimmer bipolar liner.Zimmer biomet has not assessed or confirmed the compatibility of this combination of devices, and this would be considered an off-label use of these devices.However it cannot be determined if this had any relation to the reported event.Root cause remains unchanged.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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.

Manufacturer Narrative

The following report is submitted to relay additional information received: corrected: date of event, implant date, explant date, concomitant medical products.Updated: date of event, other relevant history, brand name, pma/510k, if follow-up, what type and device evaluated by mfr.Concomitant medical products: 437644061 durasulâ standard insert size 44mm i.D.X 61mm o.D.Former centerpulse 61175864, 00620207020 shell porous with multi holes 70 mm 60077874, 00500104400 shell 44 mm o.D 61234703, 61234703 acetabular revision system - cage, right short 2409339, unknown smith and nephew head 28 mm by 16 mm neck unknown, unknown optiflex stem unknown, 00625006515 bone screw self-tapping 6.5 mm dia.15 mm length 61454699, 00625006515 bone screw self-tapping 6.5 mm dia.15 mm length 61526209, 00625006525 bone scr 6.5x25 self-tap 61515048, 00625006525 bone scr 6.5x25 self-tap 61547356, 00625006530 bone scr 6.5x30 self-tap 61526237, 00625006530 bone scr 6.5x30 self-tap 61563819, 00662406530 bone screw self-tapping 30 mm length 6.5 mm dia.61458844, 00662406535 bone screw self-tapping 35 mm length 6.5 mm dia 60713589, 00662406540 bone screw self-tapping 40 mm length 6.5 mm dia 60732352, 00662406540 bone screw self-tapping 40 mm length 6.5 mm dia 61013604.The complaint is confirmed based on the surgical op notes that were provided.Device history records were reviewed and identified no deviations or anomalies that would contribute to the reported event.A definitive root cause cannot be determined with the information provided.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: 0001822565-2018-03108, 0002648920-2018-00372, 0001822565-2018-01513, 0001822565-2018-01512.

• Brand Name: MULTIPOLAR BIPLOAR LINER 28 MM I.D. FOR USE WITH 44/45/46 MM O.D. SHELLS
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 7524365
• MDR Text Key: 108604471
• Report Number: 0002648920-2018-00371
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: PK833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2018

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?: No
• Device Operator: Physician
• Device Expiration Date: 03/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 00500104428
• Device Lot Number: 61213652
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 05/15/2018; 06/11/2018
• Supplement Dates FDA Received: 06/08/2018; 06/11/2018
• 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: 75 YR
• Patient Weight: 88