MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X MM56; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71332756
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a right hip revision surgery due to severe pain and instability.
Additional Manufacturer Narrative
The devices, intended for use in treatment, were not returned for evaluation.A clinical evaluation was conducted and per the surgical technique, the acetabular component is to be impacted with 15-20° of anteversion and 40-45° inclination angle.However, the operative report indicated the acetabular component was implanted at approximately 20-25° anteversion and during the revision the cup was noted to be anteverted significantly.It is unknown to what extent the significant anteversion impacted the patient¿s pain.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Some potential probable causes of the event could include, malposition of the device or improper device selection.Please refer to the instructions for use for recommendations on proper use of the device to prevent future reoccurrence of the reported event.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: R3 0 DEG XLPE ACET LNR 36MM X MM56
• 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: 9101208
• Report Number: 1020279-2019-03445
• Device Sequence Number: 2568352
• Product Code: MBL
• UDI-Device Identifier: 03596010598004
• UDI-Public: 03596010598004
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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: 05/08/2023
• Device Model Number: 71332756
• Device Catalogue Number: 71332756
• Device Lot Number: 13EM05296
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 01/20/2020
• 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