MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. RF INTERFIT ACET TH SZ 54 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71336054

Device Problems Mechanical Problem (1384); Unstable (1667); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Pain (1994)

Event Date 07/25/2018

Event Type  Injury  

Event Description

It was reported that patient complaining of a painful clunk when internally and externally rotating leg in flexion. Surgeon believes cup not medialised enough, is proud and a screw is perhaps irritating soft tissue. The cup also retroverted. Revision surgery. Range of motion was tested while patient asleep and surgeon reported stable -through original incision -opened joint to view implants surgeon felt once open that joint was dislocating too early with flexion and internal rotation. Head removed, liner removed, two screws removed and the cup explanted. Surgeon reamed deeper with a 58mm reamer, trialled a 58mm and then inserted a 58mm three hole r3 cup. A 40mm lateralised liner 20 degree hood was inserted after trialling and 40mm plus 8mm head inserted. Surgeon felt that this combination gave best range of motion and stability.

Manufacturer Narrative

After further investigation the cup has been considered as the primary device for this failure. This event is related to the events reported in reference: 1020279-2018-01536. 1020279-2018-01537. 1020279-2018-01539.

Manufacturer Narrative

The associated oxinium head, reflection interfit shell, reflection xlpe acetabular liner and reflection head cancellous screws were not returned for evaluation. A clinical evaluation noted that two undated x-rays were provided which do not add further to the reported clunk but it does confirm the reported orientation of the cup. Without the requested clinical information i. E. Complete revision report, and the explant a definitive root cause dislocation cannot be determined. However, the based on the report from the surgeon, the cup was not medialized and noted retroversion. Therefore, the suboptimal implantation could be a contributory factor for the reported revision. The future impact to the patient beyond the revision cannot be determined. As devices were not made available, our inspection cannot be conducted. Product details were provided. Our investigation including a review of complaint history for the listed parts revealed no prior complaints for the listed failure mode. A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes. Without the return of the actual product involved, our investigation of this report is inconclusive. Should the device or additional information be received, this complaint will be reopened and reevaluated. No further actions are being taken at this time; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: RF INTERFIT ACET TH SZ 54
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 101 hessle road; memphis TN 38116
• MDR Report Key: 7795296
• Report Number: 1020279-2018-01538
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010477279
• UDI-Public: 03596010477279
• Combination Product (y/n): N
• PMA/PMN Number: K022958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2019
• 2 Devices were Involved in the Event: 1 2
• 2 Patients were Involved in the Event: 1 2
• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/02/2022
• Device Catalogue Number: 71336054
• Device Lot Number: 12EM03847
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Outcome(s): Hospitalization