MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 SUMMIT POR TAPER SZ7 STD OFF; HIP FEMORAL STEM/SLEEVE

Catalog Number 157001135

Device Problems Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problems Inflammation (1932); Pain (1994); Synovitis (2094); Weakness (2145); Hypoesthesia (2352); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Test Result (2695); Not Applicable (3189); No Code Available (3191)

Event Date 06/09/2015

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.(b)(4).

Event Description

Litigation alleges that patient has experienced pain, difficulty walking, loosening of the implant, popping in hip, numbness, tingling, and weakness.Doi: (b)(6) 2006 dor: none reported (left side).Patient is a resident of (b)(6).Update: 11/19/2012 pfs was received from legal, medical records were received from legal, and part/lot information was identified.Records are available for further review.Update 2/17/2016-pfs and medical records received.After review of the medical records for mdr reportability, a dor was provided.The revision operative note indicated pain and synovitis.There was no mention of loosening.The right hip ((b)(4)) was revised for elevated metal ion levels-no labs), so the stem will be added to this hip as well.

Manufacturer Narrative

No device associated with this report was received for examination.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.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

(b)(4).

Event Description

Ppf alleges loosening of cup and stem, metal wear and metallosis.Added cup (b)(4), lot # at3f11000.

Event Description

New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint.- litigation alleges that patient has experienced pain, difficulty walking, loosening of the implant, popping in hip, numbness, tingling, and weakness.Doi: (b)(6) 2006, dor: none reported (left side).*patient is a resident of (b)(6).Update: (b)(6) 2012 pfs was received from legal, medical records were received from legal, and part/lot information was identified.Records are available for further review.Update 2/17/16-pfs and medical records received.After review of the medical records for mdr reportability, a dor was provided.The revision operative note indicated pain and synovitis.There was no mention of loosening.The right hip (com (b)(4)) was revised for elevated metal ion levels-no labs), so the stem will be added to this hip as well.The complaint was updated on:(b)(6) 2016.Update ad (b)(6) 2018: (b)(4) has been re-opened under (b)(4) due to receipt of ppf and sticker sheets.Ppf alleges loosening of cup and stem, metal wear and metallosis.Added cup (b)(4) lot # at3f11000.Doi: (b)(6) 2006 - dor: (b)(6) 2015 (left hip).(b)(4).

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
=
> 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.

• Brand Name: SUMMIT POR TAPER SZ7 STD OFF
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 5483108
• MDR Text Key: 39754108
• Report Number: 1818910-2016-14730
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK001991
• 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: 04/13/2012

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: 02/10/2011
• Device Catalogue Number: 157001135
• Device Lot Number: AE5EA1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 03/07/2016
• Supplement Dates Manufacturer Received: Not provided; 08/02/2018; 10/02/2018
• Supplement Dates FDA Received: 04/20/2016; 08/06/2018; 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 100