MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM; HIP FEMORAL STEM/SLEEVE

Catalog Number UNK HIP FEMORAL STEM

Device Problems Migration or Expulsion of Device (1395); Metal Shedding Debris (1804); Failure to Osseointegrate (1863); Appropriate Term/Code Not Available (3191)

Patient Problems Diarrhea (1811); Pain (1994); Rash (2033); Swelling (2091); Discomfort (2330); Osteolysis (2377); Sweating (2444); Inadequate Osseointegration (2646)

Event Date 02/04/2015

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.

Event Description

Litigation received.Litigation alleges pain, metal debris, and elevated metal ion levels.

Manufacturer Narrative

Conclusion and justification status for mdr: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Update (3/24/2017) - pfs and medical records received.After review of the medical records, in addition to what was previously reported, litigation also alleges excessive sweating, chills, hot flashes, high blood pressure, rash in groin and genitals, urinary problems, left side of face constantly swollen, digestive problems, pain in mid-and upper right abdomen, diarrhea, limping with requirement of a cane.States pain and limping resolved after revision surgery.Left hip revised for significant pain, leg shortening, and loose femoral component--left leg is "33 mm shorter" than right; stem "failed to ingrow".Intraoperatively, revising surgeon noted that the stem was "completely loose".Also indicated that the cup was in "suboptimal position", and used a 10 degree liner to "decrease the anteversion".Identified osteolysis of the proximal femur.Metal ion labs available are < 7.0 ppb and don't constitute metal ion toxicity.Implant loosening, limb length discrepancy, inflammation, and osteolysis added to complaint; elevated metal ions removed.No product/lot information available.

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.  additional 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
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> null.Device history batch
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> null.Device history review
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> null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Complaint description: litigation received.Litigation alleges pain, metal debris, and elevated metal ion levels.Update (b)(6) 2017) - pfs and medical records received.After review of the medical records, in addition to what was previously reported, litigation also alleges excessive sweating, chills, hot flashes, high blood pressure, rash in groin and genitals, urinary problems, left side of face constantly swollen, digestive problems, pain in mid-and upper right abdomen, diarrhea, limping with requirement of a cane.States pain and limping resolved after revision surgery.Left hip revised for significant pain, leg shortening, and loose femoral component--left leg is "33 mm shorter" than right; stem "failed to ingrow".Intraoperatively, revising surgeon noted that the stem was "completely loose".Also indicated that the cup was in "suboptimal position", and used a 10 degree liner to "decrease the anteversion".Identified osteolysis of the proximal femur.Metal ion labs available are < 7.0 ppb and don't constitute metal ion toxicity.Implant loosening and migration, limb length discrepancy, inflammation, and osteolysis added to complaint; elevated metal ions removed.No product/lot information available.The complaint was updated on: (b)(6) 2017 / | investigation method: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The reported event is considered one of the possible complications of joint replacement.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction (b)(4) appendix a.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.(b)(6) 2017 - investigation re-opened upon receipt of litigation paperwork and legal medical records.The new information does not affect the previous investigation.Medical records reviewed (b)(6) 2017) - (ch) from a medical perspective, based on the information available, it is not possible to determine if the complaint is product related.See attached report./ | investigation summary: litigation received.Litigation alleges pain, metal debris, and elevated metal ion levels.Doi: (b)(6) 2010 dor: (b)(6) 2015 (left hip) no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.(b)(6) 2017 - investigation re-opened upon receipt of litigation paperwork and legal medical records.The new information does not affect the previous investigation.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 5605022
• MDR Text Key: 43524939
• Report Number: 1818910-2016-17966
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 113