MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL HEAD METAL ASR; METAL FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD METAL ASR

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Joint Dislocation (2374); Osteolysis (2377); Limb Fracture (4518); Joint Laxity (4526); Metal Related Pathology (4530)

Event Date 06/06/2018

Event Type  Injury  

Event Description

Article entitled "metal-on-metal surface hip arthroplasties.Is annual monitoring of blood metal levels necessary?" written by hernández-vaquero d, garcía-pascual m, iglesias-fernández s, and escandon-rodríguez a.Published on june 6, 2018 was reviewed.The aim of our study was to present serial 7-13 year blood co and cr levels in a cohort of mom total hip arthroplasties in asymptomatic patients.52 hips were implanted with asr hemi implants.Adverse events: 8 revisions due to elevated metal ion levels.2 revisions due to alval.2 revisions due to femoral neck bone fracture.1 revision due to osteolysis.1 revision due to instability with repeated luxations.2 revisions due to pain.

Manufacturer Narrative

Product complaint # (b)(4).The size of the article is too large to attach/submit with the 3500a submission.The citation of the article has been provided below: hernández-vaquero d, garcía-pascual m, iglesias-fernández s, escandon-rodríguez a.Metal-on-metal surface hip arthroplasties.Is annual monitoring of blood metal levels necessary? rev esp cir ortop traumatol (engl ed).2018 nov-dec;62(6):436-441.English, spanish.Doi: 10.1016/j.Recot.2018.03.001.Epub 2018 jun 6.Pmid: 29884514.D4-the device catalog number is unknown; therefore, udi is unavailable.No 510(k) number provided because this implant is sold internationally with different indications for use; it was sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

• Brand Name: UNK HIP FEMORAL HEAD METAL ASR
• Type of Device: METAL FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17198063
• MDR Text Key: 317821441
• Report Number: 1818910-2023-12921
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD METAL ASR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2023
• Initial Date FDA Received: 06/26/2023
• Supplement Dates Manufacturer Received: 07/07/2023
• Supplement Dates FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention