MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. BIOLOX DELTA HEAD 32 MM 12/14 S / +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	76539160
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a subluxation of head of femoral component of hip implant due to ligamentous laxity.Event was treated with rest.No delay to the procedure.Subject id: (b)(6); date of surgery: (b)(6) 2017; age: (b)(6); sex: female.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.A clinical evaluation noted that no relevant clinical information was provided to conduct a thorough clinical investigation.No further medical assessment can be rendered at this time.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.No further investigation 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.

• Brand Name: BIOLOX DELTA HEAD 32 MM 12/14 S / +0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7820420
• Report Number: 1020279-2018-01646
• Device Sequence Number: 1351218
• Product Code: LZO
• UDI-Device Identifier: 03596010566928
• UDI-Public: 03596010566928
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 76539160
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 11/01/2018
• 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: Hospitalization