MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 49; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890249

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Distress (2329); Discomfort (2330); Test Result (2695); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/30/2016

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.Initial reporter occupation: lawyer.(b)(4).

Event Description

Asr litigation records received alleging injury, elevated chromium and cobalt levels, required revision, intense pain, soreness, discomfort, loss of range of motion, loss of earnings, loss of enjoyment of life, mental anguish, suffering, emotional pain, suffering, wounded feelings, grief, sorrow, psychological trauma, emotional upset, fear, anger, frustration and emotional distress.Doi: (b)(6) 2007 - dor: (b)(6) 2016 (left hip).

Manufacturer Narrative

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.Product complaint #: (b)(4).Investigation summary: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.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: null.Device history batch: null.Device history review: null.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.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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.H10 additional narrative: added: a2 (age), b1 (product problem), b5, b6, b7, d4, d10, g4, h4, h5.Updated: h6 (clinical, impact and medical device problem codes).H6 clinical code: appropriate term / code not available (e2402) is used to capture blood heavy metal increased.Corrected: a1, d1, d2a, d2b, g1.

Event Description

After review of medical records patient was revised was due to failed left total hip arthroplasty secondary to metallosis and trunnionosis.Prior to revision surgery patient alleges squeaking, grinding and popping in the hip.Upon entering the joint cloudy milky fluid was encountered.There was metallic debris throughout the joint and significant corrosion to the trunnion.Doi: (b)(6) 2007.Dor: (b)(6) 2016.Left hip.

Manufacturer Narrative

Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.

Event Description

The patient has passed away.Date of death: (b)(6) 2019.

• Brand Name: ASR UNI FEMORAL IMPL SIZE 49
• Type of Device: ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
• 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 orthopaedic drive; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 9267221
• MDR Text Key: 181222700
• Report Number: 1818910-2019-108934
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/17/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2012
• Device Catalogue Number: 999890249
• Device Lot Number: 2323935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/01/2019
• Supplement Dates Manufacturer Received: 10/17/2019; 06/08/2022; 09/26/2022
• Supplement Dates FDA Received: 11/01/2019; 06/08/2022; 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2007
• 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
• Treatment: ADAPTER SLEEVES 12/14 +8; ASR ACETABULAR CUPS 56; SUMMIT DUOFIX TAP SZ7 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 84 KG