MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 25MM; PRSTHSISHIPSMICONSTRIND, UNCMNTD,MTLPOLYMR,NONPROS,CALICUMPHSPHT

Model Number	71332525
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a (b)(6) year-old female had the primary hip replacement (spectron/ r3) (b)(6) 2017.Patient complained of ongoing gluteal pain.Ct review in 2019 shows acetabular screw protruding posteriorly.The patient referred to a sports doctor who advised cortisone injection around this screw which temporarily relieved pain.The surgeon recommended revision surgery to remove screw.During surgery, liner, femoral head and acetabular screw were removed following recommended surgical technique with nil issues, new liner and femoral head implanted.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed approximately 2.5 years post-implantation.Ct review shows acetabular screw protruding posteriorly.The patient reportedly underwent a revision which included explantation of the screw, along with the head and liner.The affected complaint devices, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.Review of the ifu and risk management files identified the reported failure as potential adverse events.A medical analysis noted that the provided photos of ct imaging confirm a posterior protrusion of a screw through the pelvis.Comparison images were not available for inclusion in the medical investigation; therefore, screw migration could not be confirmed.The screw protruding into the soft tissues, however, was most likely the contributing factor to the ¿ongoing gluteal pain¿.Based on this investigation, the need for corrective action is not indicated.Some potential causes could include but are not limited to alignment, patient anatomy or abnormal loading of limb.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, this complaint will be reopened and reevaluated.

• Brand Name: REF SPHER HEAD SCREW 25MM
• Common Device Name: PRSTHSISHIPSMICONSTRIND, UNCMNTD,MTLPOLYMR,NONPROS,CALICUMPHSPHT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9928894
• Report Number: 1020279-2020-01167
• Device Sequence Number: 2818349
• Product Code: MEH
• UDI-Device Identifier: 03596010460462
• UDI-Public: 03596010460462
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K990666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2020

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: 01/12/2026
• Device Model Number: 71332525
• Device Catalogue Number: 71332525
• Device Lot Number: 16MB00031
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 06/30/2020
• 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: 71343600 & 71332525.; 71343600 & 71332525
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR