MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL SLEEVE

Catalog Number UNK HIP FEMORAL SLEEVE

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/22/2014

Event Type  Injury  

Event Description

Although there are no patient specific allegations, general litigation alleges metal on metal.Update rec'd (b)(6) 2014 - pfs and medical records received.A correct doi was provided.Pfs alleges pain and several fevers.After review of the primary operative note it was discovered that the patient had a poly liner implanted, not metal.All implants are being added for pain as they cannot be excluded as the cause of pain.The stem/sleeve were also found to be loose during the revision operation.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: (b)(6) 2014.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

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

Product complaint # (b)(4).

Event Description

After review of medical records, the patient was revised to address pain and failed right total hip arthroplasty.Revision note stated, the stem was loose.The patient underwent bone scan that showed loosening of the right total hip.Doi: (b)(6) 2010 - dor: (b)(6) 2014 (right hip).

Manufacturer Narrative

Product complaint # (b)(4).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: investigation summary
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> 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.A worldwide product / 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.Investigational inputs were requested as indicated per internal procedures for this failure mode.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 wi-7915 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.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.

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.H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the injury (e20).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: replaced surgical intervention with device revision or replacement.

Event Description

Pfs alleges sharp pains inside hop and even on bone, multiple fevers.After review of medical records, the no new allegation was reported.It was indicated that during revision surgery, the cup was left in situ.

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.Update 13-sep-2021 received did not have any additional details to be added in investigation.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 manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK HIP FEMORAL SLEEVE
• Type of Device: HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 4082393
• MDR Text Key: 4851845
• Report Number: 1818910-2014-27872
• 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,other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL SLEEVE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 28IDX48OD; DELTA CER HEAD 11/13 28MM +3; PINNACLE MULTIHOLE II CUP 48MM; SROM*STM LG 30+4L 14X09X205L
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 76