MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT POR TAPER SZ5 HI OFF; HIP FEMORAL STEM/SLEEVE

Catalog Number 157011110

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Skin Irritation (2076); Swelling (2091); Tissue Damage (2104); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 07/21/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

Litigation alleges patient was revised to address pain, elevated ion levels, swelling, inflammation, damage to surrounding tissue and bone, pseudotumors, infection and lack of mobility.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other related incident(s) against the provided product/lot combination(s) since release for distribution.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.

Event Description

Update may 11, 2017: legal medical records received.After review of medical records for mdr reportability it was reported that the patient was revised to address periprosthetic osteolysis.Ct scan shows a left hip effusion, cystic changes along the iliopsoas, distention of the iliopsoas bursam, probable pseudotumor involving the anterior acetabulum with osteolysis and anterior column.Revision note indicates, the acetabular component and femoral component do not appear to be loose and a presence of a yellow-greenish effusion with no odor upon posteriorly entering the greater trochanter.Clear yellow fluid was also found when the metal liner was vibrated out.A thickened pseudotumor was pulled out from the illum.In addition there were some osteolysis around the posterior aspect of the femur.Lab report shows metal ions were above 7mcg/l.This complaint was update on: may 25, 2017.

Manufacturer Narrative

(b)(4).

Event Description

Ppf alleges metal wear and metallosis.

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.  product complaint # (b)(4).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.

Event Description

Complaint description: litigation alleges patient was revised to address pain, elevated ion levels, swelling, inflammation, damage to surrounding tissue and bone, pseudotumors, infection and lack of mobiilty.Update may 11, 2017: litigation received.After review of litigation papers, there is no new information added that changes the existing mdr decision.We are not currently reporting addional products for the alleged infection.Should we receive medical records confirming the infection, we will report the additional products at that point.Patient is bilateral.This complaint was updated on: may 16, 2017.Update may 11, 2017: legal medical records received.After review of medical records for mdr reportability it was reported that the patient was revised to address periprosthetic osteolysis.Ct scan shows a left hip effusion, cystic changes along the iliopsoas, distention of the iliopsoas bursam, probable pseudotumor involving the anterior acetabulum with osteolysis and anterior column.Revision note indicates, the acetabular component and femoral component do not appear to be loose and a presence of a yellow-greenish effusion with no odor upon posteriorly entering the greater trochanter.Clear yellow fluid was also found when the metal liner was vibrated out.A thickened pseudotumor was pulled out from the illum.In addition there were some osteolysis around the posterior aspect of the femur.Lab report shows metal ions were above 7mcg/l.This complaint was update on: may 25, 2017 / | investigation method: no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination(s).Based on the inability to find any additional related reports against the provided product code/lot code combination(s) it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.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 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./ | investigation summary: litigation alleges patient was revised to address pain, elevated ion levels, swelling, inflammation, damage to surrounding tissue and bone, pseudotumors, infection and lack of mobiilty.Doi (b)(6) 2010 dor (b)(6) 2015 (left hip).No device associated with this report was received for examination.A worldwide complaint database search found no other related incident(s) against the provided product/lot combination(s) since release for distribution.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.

• Brand Name: SUMMIT POR TAPER SZ5 HI OFF
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6277295
• MDR Text Key: 65730472
• Report Number: 1818910-2017-11434
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: P040023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 157011110
• Device Lot Number: D55DS1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 84