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

Catalog Number	76539160
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presents iliopsoas tendinitis on operative hip.This was found after surgery.Device back up not applicable and delay during procedure is unknown.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and it was reported iliopsoas tendinitis of operative hip occurred three years post implantation.However, only the primary operative report was provided and reviewed and does not contribute to the reported issue.Without the relevant clinical information, labs, radiographs, trauma history, physical activity level or the explant we are unable to conduct a thorough medical assessment.Should any additional clinical information becomes available this complaint will be re-assessed.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.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: BIOLOX DELTA HEAD 32 MM 12/14 S / +0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8266446
• Report Number: 1020279-2019-00230
• Device Sequence Number: 16653013
• 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): 06/18/2019

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: No Information
• Device Catalogue Number: 76539160
• Initial Date Received by Manufacturer: 01/01/2019
• Supplement Date Received by Manufacturer: 01/01/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 57