MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EPOLY RLC 36MM 10DEG SZ24; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 650-1057 cer bioloxd option hd 36mm 2934973, 650-1066 cer opt type 1 tpr sleve 0mm 2920992, pt-116056 regen/rnglc+ ltd 56mm sz 24 240160, 010000994 g7 apical hole plug 6102385, 51-108080 tprlc 133 mp t1 pps so 8x101mm 6006745, 103532 ti low profile screw 6.5x25mm 181420, 106024 ringloc+ replacement ring sz24 304650.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.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: 0001825034 - 2020 - 00293 shell, 0001825034 - 2020 - 00294 hole plug, 0001825034 - 2020 - 00295 taper, 0001825034 - 2020 - 00296 screw, 0001825034 - 2020 - 00297 ring.

Event Description

It was reported that patient underwent right revision and subsequently, patient underwent another revision a year and a half later due to infection.All components were removed and a cement spacer implanted.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

Reported event was confirmed by review of medical records and radiographs provided.Preoperative notes state patient presents with right lower extremity pain and weakness, leg gave out, he fell, was seen in emergency room.Pt using a walker.Pain is 9 on 0-10 scale.Pt has known right sided sciatica and lumbar degenerative disc disease.Physical assessment shows no contracture, no effusion, pt does have pelvic obliquity (tilted/misaligned pelvis) with standing.Images taken show right hip tha in place, no subsidence or loosening, no evidence of failure.Left hip degenerative changes, femoral neck fracture with angulation and minimal displacement, degenerative changes versus osteonecrosis.Mild lumbar sacral degenerative changes, lordosis.Admitted to hospital for left femoral neck fracture.The patient was assessed by orthopedic surgeon and right hip does not appear to have caused or contributed to the fall and left hip fracture.Pt then referred to primary care provider.Revision operative record indicates infection, worsening right thigh pain, signs of chronic infection.Onion skinning or reactive bone over the portion of the femur distal to the implant, femur was difficult because of bony sclerotic bridging across the medullary canal.Pre/postop diagnosis: infected right tha, impending femoral shaft fracture.Vancomycin & tobramycin (antibiotics) placed in cement ¿ 3 batches of cement used.Postop: limb lengths were symmetrical, rom full flexion, abduction limited to about 20 degrees with impingement of the neck onto the acetabular component.Excellent bone quality, estimated blood loss 450ml, general anesthesia, posterior approach.There was excessive scar tissue in the hip which was debrided.Specimens sent for cultures: reamings of the femur (results not provided).Patient transported to recovery in stable condition.50% flatfoot partial weight bearing with walker until gains better control of leg.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: EPOLY RLC 36MM 10DEG SZ24
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9608265
• MDR Text Key: 176081242
• Report Number: 0001825034-2020-00298
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00880304455245
• UDI-Public: 00880304455245
• Combination Product (y/n): N
• PMA/PMN Number: K100048
• 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: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2020
• Device Model Number: N/A
• Device Catalogue Number: EP-105894
• Device Lot Number: 842180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2020
• 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 Weight: 95