MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 28MM X 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71334946
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a tha surgery, the locking mechanism of 46mm outer cup and 46mm liner caused the liner could not be implanted, it was loose, and it didn't work even after trying several times.Finally a 48mm liner was used to complete the surgery.There was a delay between 31-60m min.
Additional Manufacturer Narrative
It was reported that during a tha surgery, the locking mechanism of 46mm outer cup and 46mm liner caused the liner could not be implanted, it was loose, and it didn't work even after trying several times.Finally a 48mm liner and 48mm cup were used to complete the surgery.There was a delay between 31-60m min.The affected r3 acetabular liner, intended for use in treatment, was returned and evaluated.A visual inspection of the device shows signs of damage, probably from attempted use.Our quality team completed dimensional analysis on the returned product and noted that upper bead crest is oversized, but the surface of the diameter is visually damaged/distorted around the part, especially on the upper bead crest, which is the mating for the liner with the inner groove of the r3 shell.Plastic is easily distorted during attempted implantation, especially when attempting to mate with a rigid surface like the titanium on r3 shells.These surface finish changes (dings, scratches, scuffs, rubs) are sufficient to alter the measured reading during evaluation.For this reason, the cause of the complaint cannot be confirmed as the result of a non-conforming part.No further action will be taken at this time.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.Based on this investigation, the need for corrective action is not indicated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.No medical documents were received for investigation.Therefore no further clinical assessment is warranted.Some potential causes of the reported event could include but are not limited to surgical technique used, size of device or user/procedural variance.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: R3 20 DEG XLPE ACET LNR 28MM X 46MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10199296
• Report Number: 1020279-2020-02763
• Device Sequence Number: 13714527
• Product Code: MBL
• UDI-Device Identifier: 03596010598097
• UDI-Public: 03596010598097
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021

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 Model Number: 71334946
• Device Catalogue Number: 71334946
• Device Lot Number: 19EM11514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 03/05/2021
• 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; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 56