MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. ¿ REG. # 8010379 UNKNOWN DEPUY FEMORAL HEAD; HIP FEMORAL HEAD

Catalog Number UNK-HIP

Device Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544); No Code Available (3191); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/17/2014

Event Type  Injury  

Event Description

Litigation alleges the patient suffers from large amounts of toxic cobalt-chromium metal ions and particles to be released into the blood, tissue and bone.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The device associated with this report was not returned.A search of the complaint database and/or dhr review was not possible as the product and lot code required was not provided.The investigation could not draw any conclusions regarding the reported event with the information available.Based on the inability to determine a root cause, the need for corrective action was not indicated.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

Manufacturer Narrative

The device associated with this report was not returned.Review of the device history records and/or a lot specific complaint database search was not possible as the product and lot code required was not provided.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Photographs of the explanted liner and femoral head have been provided for review.There is nothing unusual of note that would suggest product error.Nothing indicative of product problem was identified.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 : a device manufacturing (mre) review will not be performed even when product/lot information is known.Per wi-3430 it has been determined that, for the mom platform and related allegations an mre is not required.

Event Description

After review of medical records it was reported that the patient complained of pain, fatigue, diff walking, crouching and sleeping with increase cobalt and chromium levels.The patient was then revised for possible tissue reaction left tha, metal on metal.Operative notes reported that patient has bilateral hip implants.Left side been slightly painful.On note there did not appear to be any adverse wear on the inside aspect of the acetabular shell nor over the trunnion or inside the femoral head.No labs provided for the alleged elevated metal ions.Pathology reported of trunnion left hip for metal debris.Acellular fibrinous material with small number of microscopic particles compatible with metallic debris.The specimen consist of several fragments of pink-purple irregular shape, evaluate for alval.X-rays reported of trochanteric bursitis.Mri reported of pseudotumor, lysis, effusion and erosion.Doi: (b)(6) 2011.Dor: (b)(6) 2013.

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.H10 additional narrative:  added: a2 (dob, age), (clinical, medical device problem and impact codes).Udi (b)(4).E3 initial reporter occupation: lawyer.H6 clinical code: appropriate term / code not available (e2402) is used to capture blood heavy metal increased and pocket erosion (e1713).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNKNOWN DEPUY FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. ¿ REG. # 8010379; st. anthony's rd; leeds, leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 3833264
• MDR Text Key: 4447812
• Report Number: 1818910-2014-19418
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,consumer,other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/20/2014

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: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: UNK-HIP
• Device Lot Number: 3188908
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2014
• Initial Date FDA Received: 05/27/2014
• Supplement Dates Manufacturer Received: Not provided; 06/17/2021; 07/07/2021
• Supplement Dates FDA Received: 07/01/2014; 07/01/2021; 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP.; PINN 100 W/GRIPTION 50MM.; PINNACLE MTL INS NEUT36IDX50OD.; SUMMIT POR TAPER SZ1 HI OFF.
• Patient Outcome(s): Other
• Patient Age: 58 YR