MAUDE Adverse Event Report: EXACTECH, INC. NV CROWN CUP CLSTR HOLE 56MM GROUP 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	180-01-56
Medical Device Problem Codes	Unstable (1667); Loss of Osseointegration (2408); Loosening of Implant Not Related to Bone-Ingrowth (4002); Lack of Effect (4065)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577); Aseptic loosening (4883)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.136-56-36 liner 3780249.
Event or Problem Description
As reported, this female patient had a left side revision of the cup and liner due to pain and loosening.X-rays show a large boney defect around the cup.A new exactech head was implanted.The devices are not available for return.There was no reported breakage of devices or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of an insufficient bond between the acetabular cup and the bone, patient-related conditions, or a combination of these possibilities, which led to aseptic (non-infected) acetabular cup loosening and pain.However, this cannot be confirmed as the devices were not returned for evaluation.D10: 136-56-36 liner 1644210.
Event or Problem Description
Additional information provided via legal department - revision operative report of (b)(6)2022- revision with a complex reconstruction of the left acetabulum using 60 ml of cancellous chip bone graft.The patient was noted to have extensive osteolysis and achiness in his hip.Procedure: prior to opening the capsule, they drained the hip joint of a few ml of clear fluid.This was sent for routine culture.At this point, reopening up the capsule noted to be quite thickened.The femoral stem appeared to be stable.Visualization of the acetabulum, to explant the device and removed some scar tissue around the edges, but then also noted that the cup was mobile they noted the significant deformity of the acetabulum with fragmenting of the acetabular liner.They were able to remove the metal acetabular easily.Once they removed the cup, they exposed a very major supraacetabular defect as well as medially.They removed all cheesy type material, and the fibrous membrane along the supraacetabular cyst.The whole acetabulum appeared to be somewhat spongy with slight deficiencies and defects in the anterior and posterior wall.They inserted the acetabulum in a position of about 45 degrees abduction and 50 degrees anteversion and inserted screws superiorly but did not get any purchase they changed the position of the screws and still because of the large supraacetabular defect could not get purchase, they then placed the cup at this point now in a more less abducted position, probably more about 35 degrees of abduction and at this time, and were able to get good purchase with a 20 mm dome screw.Prior to doing this screw, they tapped the cup, noted that there is a small medial wall crack, but the cup appeared to be stable.They had very stable fixation with this one screw.Sterile dressings applied and the patient was taken to recovery room in satisfactory condition.No additional information.
Additional Manufacturer Narrative
Additional information - b5.This information does not alter the investigation results.These devices are used for treatment not diagnosis.There is no other information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d8, d10, h6: clinical codes, component code, investigation findings and investigation conclusion.D10: 1644210 136-36-53 - nv gxl lnr, +5lat, 36mm g3-56/58mm cups.2601604 120-65-25 - bone screw 6.5mm dia x 25mm long.2698568 101-05-20 - 3.2mm drill bit 20mm 1pk.2701174 164-03-11 - element-stem, collared w/ha, std offset, sz 11.2710675 170-36-00 - biolox delta femoral head 36mm od, +0mm.2724885 120-65-20 - bone screw 6.5mm dia x 20mm long.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NV CROWN CUP CLSTR HOLE 56MM GROUP 3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15128265
• Report Number: 1038671-2022-00857
• Device Sequence Number: 6626300
• Product Code: JDI
• UDI-Device Identifier: 10885862037039
• UDI-Public: 10885862037039
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/29/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2018
• Device Model Number: 180-01-56
• Device Catalogue Number: 180-01-56
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/11/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 04/28/2023; 05/30/2023; 11/25/2025; 06/26/2026
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 05/11/2023; 06/29/2023; 12/08/2025; 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female