MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. MULTIPOLAR CUP; PROSTHESIS, HIP

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Debris, Bone Shedding (1803); Unspecified Infection (1930); Pain (1994); Local Reaction (2035); Joint Dislocation (2374); Reaction (2414)

Event Date 01/11/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00620207220, trabe metal mod cup multi-hole, 60592636, 437644067, durasulâ¿¢ standard insert size 44mm, 60592636, 00625006515, bone screw selftapping 6.5 mm, 60713479, 00625006515, bone screw selftapping 6.5 mm, 60773963, 00625006520, bone screw selftapping 6.5 mm, 60959537, 00625006535, bone screw selftapping 6.5 mm, 60965163, 00625006540, bone screw selftapping 6.5 mm, 60838382, 00625006550, bone screw selftapping 6.5 mm, 60990156, 00625006560, bone screw selftapping 6.5 mm, 60732348, unknown, optiflex stem, unknown, unknown, unknown smith and nephew head 28mm /16 mm neck, unknown, 00500104428, pe bipolar liner 28 mm, 60722508.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: 0001822565 - 2018 - 01519, 0001822565 - 2018 - 01518, 0002648920 - 2018 - 00350, 0002648920 - 2018 - 00351, 0002648920 - 2018 - 00352, 0002648920 - 2018 - 00353, 0002648920 - 2018 - 00354, 0002648920 - 2018 - 00355, 0002648920 - 2018 - 00356.Product location unknown.

Event Description

It was reported that the patient underwent a two stage revision due to infection, loosening, pain, metallosis, pseudotumor, dislocation, and instability.Attempts have been made and additional information on the reported event is unavailable.

Event Description

It was reported that the patient underwent right hip two stage revision for bone loss, loosening, pain, metallosis, pseudo tumor, infection and dislocation.Intraoperative findings show that the screws were loose or fractured and intraoperative frozen sections were found negative.No other additional information is available.

Manufacturer Narrative

The follow up report is submitted to relay corrections and additional information received: concomitant medical products:: 00620207020 shell porous with multi holes 70 mm 60077874.437644061 durasulâ¿¢ standard insert size 44mm i.D.X 61mm o.D.Former centerpulse 61175864.00500104428 liner 28 mm i.D.For use with 44/45/46 mm o.D.Shells 61213652.61234703 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 screw self- tapping 6.5 mm dia.25mm length 61515048.00625006525 bone screw self- tapping 6.5 mm dia.25mm length 61547356.00625006530 bone screw self- tapping 6.5 mm dia.30mm length 61526237.00625006530 bone screw self- tapping 6.5 mm dia.30mm length 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 was provided.Device history records were reviewed identified no deviations or anomalies would contribute to reported event.Multipolar® bipolar cup liner is not compatible with unknown competitor¿s head.Multipolar® bipolar cup shell is not compatible with durasul liner.During second stage significant heterotopic ossification was found and was removed before re - implantation.A definitive root cause cannot be determined with the information provided.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-01519, 0001822565-2018-01518, 0002648920-2018-00478, 0002648920-2018-00350, 0002648920-2018-00351, 0002648920-2018-00352, 0002648920-2018-00353, 0002648920-2018-00354, 0002648920-2018-00355, 0002648920-2018-00356, 0002648920-2018-00484, 0002648920-2018-00485.

• Brand Name: MULTIPOLAR CUP
• 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: 7519775
• MDR Text Key: 108481312
• Report Number: 0002648920-2018-00349
• 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
• Report Date: 06/14/2018

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/06/2019
• Device Model Number: N/A
• Device Catalogue Number: 00500104400
• Device Lot Number: 61234703
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 05/15/2018
• Supplement Dates FDA Received: 06/14/2018
• 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: 74 YR