MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 50MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	74122550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
Us legal.It was reported that, after a bhr-tha construct had been implanted on the patient¿s right hip on (b)(6) 2009, the patient experienced unspecified symptoms that were addressed with a prosthesis replacement.A revision surgery was performed on (b)(6)2019; during this procedure the hemi head 50mm was explanted and replaced with an oxinium femoral head with a -3 setting 12/14 taper and a dual mobility liner.The patient¿s outcome is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that a right hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, have been requested for this complaint but has not become available.A review of the historical complaints data for the hemi head and for the sleeve was performed.Using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.No other similar complaints were identified to involve this batch for the hemi head and for the sleeve.No other similar complaints have been identified for the part number and the reported failure mode for the sleeve.Other similar complaints have been identified for the part number and the reported failure mode for the hemi head.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.All the released devices involved met manufacturing specifications upon release for distribution.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.Hemi heads, sleeves have been phased out from the market and as a result there is no live risk management file to review.Therefore, an evaluation of failure modes is not required.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions required.The available medical documents were reviewed.It should be noted the acetabular cup was ¿impacted it at 40 to 45 degrees of inclination and 20 to 25 degrees of anteversion.¿ the surgical technique (01/07 4567-0103) indicates, the acetabular component is to be ¿fully impacted with 15-20° of anteversion and 40-45° inclination angle.¿ with the information provided the clinical root cause for the revision cannot be confirmed.It cannot be concluded there was a malperformance of the implant.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.Based on the available information we can confirm the reported complaint, however without further information our investigation remains inconclusive, and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If additional information becomes available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: HEMI HEAD 50MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14047444
• Report Number: 3005975929-2022-00134
• Device Sequence Number: 20027537
• Product Code: KWL
• UDI-Device Identifier: 00885556071205
• UDI-Public: 885556071205
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2013
• Device Catalogue Number: 74122550
• Device Lot Number: 08GW18100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 06/10/2022
• Date Device Manufactured: 07/31/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACETLR CUP HAP 56MM W/ IMPTR-086023; ANTHOLOGY SO POR PL HA SZ 9-07KM20608A; MODULAR SLEEVE -4MM 12/14-08BW15649
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male