MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BIRMINGHAM HIP; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Toxicity (2333); Injury (2348)

Event Type  Injury  

Event Description

Surgeon presented at a closed hip society meeting and reported on 173 primary surgeries and 87 revision due to pseudotumour and elevated metal ion levels (57 performed of which were performed by the presenting surgeon).

Manufacturer Narrative

As of today, device return and additional information has been requested for this complaint but has not become available.Since neither the underlying medical documents nor device part details were received for investigation no thorough medical investigation, manufacturing record review and assessment of the reported event can be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case,.

• Brand Name: BIRMINGHAM HIP
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 8576753
• MDR Text Key: 143932809
• Report Number: 3005975929-2019-00191
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 05/03/2019
• Supplement Dates Manufacturer Received: 04/04/2019
• Supplement Dates FDA Received: 07/10/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention