MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) HEMI; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number 74122552

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 11/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient underwent a revision surgery on november 11th associated to pain and elevated ion levels in the blood.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review and device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.Although the reported elevated metal ions, pseudotumor and trunnionosis may be consistent with metal debris, without the supporting lab results and/or the analysis of the explanted components, the root cause of the reported elevated ions, pseudotumor and trunnionosis cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

Event Description

It was reported that the patient underwent revision surgery of the right hip on (b)(6) 2020 due to toxic levels of cobalt and chromium, secondary to trunionosis and, additionally, painful hips showed joint effusions on mri.The metallic femoral head was explanted and replaced with a dual mobility inset and an oxonium femoral head.The patient was returned to the pacu without complication.

Manufacturer Narrative

Sections a2, a3, b3, b5, d3, d4, d10 and h6 were updated according to the new information received.Internal complaint reference number: case (b)(4) section d2 was corrected according to the new information received.

Manufacturer Narrative

H3, h6: it was reported that right hip revision surgery was performed.During the revision, the hemi head and modular sleeve were explanted.The acetabular cup and stem remained implanted.A hemi head (part no.74122552, batch no.Unknown) and a modular sleeve (part no.Unknown, batch no.Unknown) used in treatment were received for investigation.As of today, additional information has been requested for this complaint but has not become available.Without definitive part/lot numbers a complete complaint history review cannot be performed for the acetabular cup, stem or modular sleeve involved.Without a definitive batch number, a complete complaint history review cannot be performed for the hemi head.A review of the historical complaints data for the hemi head was performed using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.No other similar complaints have been identified for the part number and the reported failure mode in this timeframe.As no device batch numbers were provided for investigation, a manufacturing record review and device labelling / ifu review could not be performed.However, the released devices would have met manufacturing specifications at the time of production.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.Visual inspection was performed on the returned devices.Fine scratches and discoloration were observed on the bearing surface of the hemi head.Surface texture change and discoloration were observed on the internal sleeve taper.Wear analysis was performed to review linear wear on the bearing surface of the hemi head.The wear images identified a wear patch on the bearing surface of the hemi head.Maximum linear wear for the hemi head was 10.1m.Measurement of the vertical straightness profile of the internal sleeve taper showed material loss to a maximum depth of 128.0m.Based on historic wear data, after 9 years in vivo, the measured linear wear on the bearing surface of the head is in line with the expected head wear for a non-edge loaded smith and nephew large diameter metal-on-metal device.Material loss was measured on the internal taper of the sleeve.The available medical documents were reviewed.Although the reported elevated metal ions and pseudotumor may be consistent with metal debris; the root cause of the reported elevated ions and pseudotumor cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal performance of the implant.The patient impact beyond the revision and expected transient post-operative convalescence period cannot be determined.Without additional information we cannot advance the investigation or confirm this complaint; our investigation remains inconclusive, and a definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.Should additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) HEMI
• Type of Device: 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: 11099856
• MDR Text Key: 224519854
• Report Number: 3005975929-2020-00530
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/23/2021

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 74122552
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 01/26/2021; 08/12/2021; 12/21/2021
• Supplement Dates FDA Received: 01/27/2021; 08/17/2021; 12/23/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK BIRMINGHAM HIP MODULAR HEAD SLEEVED MODULAR; UNKN ANTHOLOGY HIP IMPLANT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male