MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX DELTA HEAD 40MM 12/14 SHORT+0; PROST, HIP, SEMI-CONS, METAL/CER/POLY, CEM OR NON-POROUS, UNCE

Model Number	71346004
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	07/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent two closed reductions due to recurrent dislocations.The first closed reduction was performed on (b)(6) 2018 and the second one on (b)(6) 2018.
Additional Manufacturer Narrative
The devices, used in treatment were not returned for evaluation, reporting event could not be confirmed.A lab analysis confirms based on this investigation, it was concluded the stem fractured by the initiation and subsequent propagation of fatigue cracking.The fatigue cracking eventually propagated to an extent that the remaining cross section could not bear the imposed patient loading, which led to an overload fracture.Fatigue cracking is caused by cyclic stresses in excess of the material endurance limit for an extended period of time.These excessive cyclic stresses may be caused by any applications of loads in excess of the material¿s strength.The appearance of lack of proximal support along with evidence that the distal stem was fixed supports a conclusion that an overloading condition occurred.This most likely is the reason for the stem fracture.No material or manufacturing deviations were observed during this investigation.A clinical evaluation was conducted and confirms without the requested clinical information a thorough medical investigation cannot be rendered.Should any additional clinical information be provided this complaint will be re-evaluated.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 device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.
Event or Problem Description
It was reported that the patient underwent two closed reductions, followed by revision surgery of liner, head and sleeve due to recurrent dislocations.The first closed reduction was performed on (b)(6) 2018 and the second one on (b)(6) 2018.Finally, the revision surgery was performed on (b)(6) 2019.
Additional Manufacturer Narrative
Results of investigation: the devices, used in treatment, were returned for evaluation.A lab analysis concluded the stem fractured by the initiation and subsequent propagation of fatigue cracking.The fatigue cracking, caused by cyclic stresses in excess of the material endurance limit for an extended period of time, eventually propagated, that the remaining cross section could not bear the imposed patient loading; which led to an overload fracture.Cyclic stresses may be caused by any applications of loads in excess of the material¿s strength.Lack of proximal support along with evidence that the distal stem was fixed supports a conclusion that an overloading condition occurred.This most likely is the reason for the stem fracture.A clinical evaluation indicated the reported obvious non-union with proximal femur ¿rotationally unstable/rotating about the stem¿ at 16 months post-2nd revision was most likely the contributing factor to the periprosthetic fracture, sleeve failure, bone and tissue debris/necrosis about the site, requiring a revision with bone grafting, orif, cerclage, and antibiotic therapy.It cannot be ruled out that the two prior dislocations also could have contributed to the extent of the mal/non-union.The patient impact beyond the reported clinical findings and reported interventions with 3rd revision procedure could not be determined.A review of complaint history on the listed parts revealed no prior complaints for the listed batches.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document for this failure mode was conducted.Possible causes could include but not limited to traumatic injury or abnormal loading of limb.The need for corrective action is not indicated.We consider this investigation closed.

• Brand Name: BIOLOX DELTA HEAD 40MM 12/14 SHORT+0
• Common Device Name: PROST, HIP, SEMI-CONS, METAL/CER/POLY, CEM OR NON-POROUS, UNCE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9653047
• Report Number: 1020279-2020-00426
• Device Sequence Number: 2844430
• Product Code: LZO
• UDI-Device Identifier: 03596010656711
• UDI-Public: 03596010656711
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020

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: No Information
• Device Expiration Date: 06/27/2020
• Device Model Number: 71346004
• Device Catalogue Number: 71346004
• Device Lot Number: 10FT43474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 05/20/2020; 10/30/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 05/25/2020; 11/12/2020
• 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
• Patient Age: 66 YR