MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. REF XLPE 36 20 DEG 54-56 F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71333345
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/25/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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: REF XLPE 36 20 DEG 54-56 F
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7795361
• Report Number: 1020279-2018-01539
• Device Sequence Number: 10793183
• Product Code: LPH
• UDI-Device Identifier: 03596010479754
• UDI-Public: 03596010479754
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K022902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71333345
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization