MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STANDARD OFFSET NEUTRAL MODULAR NECK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71352111
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/08/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to chronic infection and metallosis.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and although the intraoperative findings may be consistent with an adverse reaction to metal debris, currently unable to rule out the primary cup orientation, acetabular fracture and subsequent stem loosening as the contributing factors for the ¿metallosis¿.The presence of infection 3 weeks post implantation of smith and nephew components does not reflect a ¿chronic infection¿.It is likely, therefore, that there was a pre- existing infection prior to the implantation of the smith and nephew prostheses; however, no lab or pathology results were provided.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the source of the reported infection and/or metallosis cannot be confirmed.The patient impact beyond the reported intra-op findings during explanation and repeated left hip debridements, antibiotic therapy and revision tha cannot be determined.No further medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.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.We consider this investigation closed.

• Brand Name: STANDARD OFFSET NEUTRAL MODULAR NECK
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7827547
• Report Number: 1020279-2018-01660
• Device Sequence Number: 11059841
• Product Code: LPH
• UDI-Device Identifier: 03596010619532
• UDI-Public: 03596010619532
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2018

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: 02/06/2026
• Device Catalogue Number: 71352111
• Device Lot Number: 15MTM0007A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 12/22/2018
• 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: Other; Required Intervention