MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71338666
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to cup loosening confirmed by x rays.During the first stage revision of the left hip, the surgeon extracted a r3 multihole cup, liner and femoral head and reflection screws.The xlpe liner shows damage to posterior wall and the femoral head shows damage.Metallosis could be detected in the soft tissue of the acetabulum.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.The lab analysis concluded, there is evidence to support the root cause for this issue is at least one of the screws was left unseated in its screw hole.The screw head being left above the shell id surface, did not allow for the liner to be seated and locked into place.The loose liner ultimately lead to the need to revise these implants.Also, the impingement of the screw head with the liner most likely produced wear debris which is what was reported seen in the surrounding tissue.The clinical/medical team concluded, the reported metallosis may be consistent with an adverse reaction to metal debris from the reported motion of the shell or impingement from the stem neck and shell.Lab analysis of the explanted devices indicates there was likely impingement of the screw head with the poly liner, as well as the poly liner with the neck of the femoral component, which most likely produced wear debris.This would be consistent with the reported complaint, however without the supporting lab/pathology results, metallosis cannot be confirmed.The loosening of the shell and migration over time cannot be concluded on the single image provided.The failure of this liner seating is likely due to the screw not being seated but whether this was not seated during implant vs migration over time cannot be concluded.The patient impact beyond the revision and associated post-operative healing pain cannot be determined.No further clinical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.If new information is received in the future, this complaint can be re-opened.

• Brand Name: R3 MULTI HOLE ACETABULAR SHELL 54MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8150387
• Report Number: 1020279-2018-02741
• Device Sequence Number: 11332802
• Product Code: MBL
• UDI-Device Identifier: 00885556021804
• UDI-Public: 00885556021804
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K092386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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 Expiration Date: 05/01/2023
• Device Catalogue Number: 71338666
• Device Lot Number: 13EM02006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACET LINER 71335754 LOT 13HM20232; FEMORAL HEAD 71343600 LOT 13JM14595; HEAD SCREW 71332525 LOT 09HM18431; HEAD SCREW 71332540 LOT 10BM02505; HEAD SCREW UNKNOWN PART UNKNOWN LOT; ACET LINER 71335754 LOT 13HM20232; FEMORAL HEAD 71343600 LOT 13JM14595; HEAD SCREW 71332525 LOT 09HM18431; HEAD SCREW 71332540 LOT 10BM02505; HEAD SCREW UNKNOWN PART UNKNOWN LOT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 75