MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN R3 CERAMIC LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number UNKNOWN

Device Problem Malposition of Device (2616)

Patient Problem Deformity/ Disfigurement (2360)

Event Date 10/07/2017

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Teoh, k.H., whitham, r.D., golding, d.M., wong, j.F., lee, p.Y., & evans, a.R.(2018).R3 cup does not have a high failure rate in conventional bearings: a minimum of 5-year follow-up.The journal of arthroplasty, 33(2), 460-463.Doi: https://doi.Org/10.1016/j.Arth.2017.09.059.

Event Description

It was reported that, on the literature review "r3 cup does not have a high failure rate in conventional bearings: a minimum of 5-year follow-up", one (1) patient who initially underwent primary thr implantation with an r3 acetabular cup and a cementless polarstem required a revision surgery due to malalignment of the ceramic liner associated to the r3 cup.Postoperative radiographs revealed that the liner looked flush on superior and posterior area, but was offset by 1-2 mm in the inferior and anterior are with no soft tissue interposition found.The patient's outcome is not known.No further information is available.

Manufacturer Narrative

H10: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per the complaint, no further information is available.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Internal complaint reference number: (b)(4).

• Brand Name: UNKN R3 CERAMIC LINER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14714739
• MDR Text Key: 294168492
• Report Number: 1020279-2022-03021
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 07/19/2022
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKN FEMORAL HEAD IMPL; UNKN R3 SHELL; UNKN. POLARSTEM CEMENTLESS (TI/HA)
• Patient Outcome(s): Other; Hospitalization