MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DEPUY ASR FEM IMPLANT SZ 46; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890046

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Headache (1880); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 04/17/2012

Event Type  Injury  

Event Description

Complaint description: new etq created in order to update etq (legacy system) complaint number: (b)(4).Reason for original complaint: litigation alleges that the patient suffered pain, disability, fluid around hip implant, excessive levels of chromium and cobalt, soft tissue destruction, bone loss, limited range of motion and neurological symptoms.Update: on (b)(6) 2013, plaintiff¿s preliminary disclosure form was received, which identified dob.The complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.Update: on (b)(6) 2013, medical records received.Patient was revised to address metal debris and excessive joint fluid.The information received does not change the mdr decision.This complaint was updated on: 1/29/2014.Update 10/18/2016 supplemental information received.There is no new additional information that would affect the existing mdr decision or the investigation.Complaint was updated 10/26/2016.Additional information: doi: on (b)(6) 2007, dor: on (b)(6) 2012 (right hip).Patient is a resident of ca.Complaint file contents attached a.B.On (b)(6) 2014.Link to the complaints or capa.Attachment: (b)(6) asr supplemental (b)(6) 2016.Msg, (b)(6) medical records(b)(6) 2013.Pdf, (b)(6) medical records (b)(6) 2013.Pdf, (b)(6) ppd (b)(6) 2014.Pdf, (b)(4).Pdf.

Manufacturer Narrative

Product complaint#: (b)(4).Initial reporter occupation: lawyer.Component code: appropriate term/code not available (g07002) used to capture no findings available.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.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.

Event Description

Pfs reported the result of blood metal ions were elevated.Patient complained of headaches, feeling achy and fatigue, unable to perform activities de to excruciating hip pain and pronounced hip.Fluid exam revealed particulate debris.On (b)(6) 2011, evaluation reported with symptoms of constant pain in groin area, fatigue, headache and cluncking sound when bend over.On (b)(6) 2011, patient returned to primary physician to report black discoloration of hand, abnormal discomfort, tingling in foot, twitching lip, decreased sensation in right sacrum area and change in eyesight.On (b)(6) 2012, consultation report that patient also complaints of excessive bruising, digestive problems and neurological sensations, and stress.On (b)(6) 2012, revision surgery was performed.

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: DEPUY ASR FEM IMPLANT SZ 46
• 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 dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16351224
• MDR Text Key: 309267248
• Report Number: 1818910-2023-03437
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 02/10/2023

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: 999890046
• Device Lot Number: 2326420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/10/2023
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2007
• 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: ASR ACETABULAR CUPS 52; DEPUY ASR FEM IMPLANT SZ 46; DEPUY1 GENTAMICIN CEMENT 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female