MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX DELTA HEAD 36 MM 12/14 M / +4; PROSTHESISHIPSMICONSTRAINDMETALCERAMICPOLYMERCMNTDORNONPOROUSUNCMNTD

Model Number	76539166
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had low haemoglobin and required 3 units of blood transfusion.
Additional Manufacturer Narrative
It was reported that patient had low haemoglobin and required 3 units of blood transfusion.The affected r3 acetabular shell, anthology high offset stem, biolox delta head and r3 delta ceramic liner, used in treatment, were not available for evaluation as they are still implanted.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.Without any supporting medical documentation, a thorough medical assessment cannot be performed.It was stated that the reported event was caused by the procedure as the patient had low haemoglobin.Based on this investigation, the need for corrective action is not indicated.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.We consider this investigation closed.

• Brand Name: BIOLOX DELTA HEAD 36 MM 12/14 M / +4
• Common Device Name: PROSTHESISHIPSMICONSTRAINDMETALCERAMICPOLYMERCMNTDORNONPOROUSUNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9670763
• Report Number: 1020279-2020-00475
• Device Sequence Number: 380155
• Product Code: LZO
• UDI-Device Identifier: 03596010566966
• UDI-Public: 03596010566966
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,study,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2020

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 Model Number: 76539166
• Device Catalogue Number: 76539166
• Device Lot Number: 09DT30511
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 06/22/2020
• 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