MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM M HEAD 36MM +0; HIP FEMORAL HEAD

Catalog Number 136531000

Device Problems Material Disintegration (1177); Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Pain (1994)

Event Date 09/26/2011

Event Type  Injury  

Event Description

New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint ¿ patient was revised to address metallosis.Update: (b)(6) - received ct report, pathology report, revision surgery operative notes, clinical correspondence in the joint due to impingement between the neck of the stem and the cup.Ion testing did not show elevated levels of cobalt or chromium.Update (b)(6) 2014 - pfs and medical records received.This complaint is now legal.Pfs alleges pain, trouble walking, and trouble performing daily activities.A doi was provided.No revision operative note was provided.The femoral head and liner are being added due to the alleged pain.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: (b)(6) 2015.

Manufacturer Narrative

Udi: (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.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported 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 at this time.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

In addition to previous allegations, ppf alleges metal wear.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.A worldwide complaint database search found no other reported 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: S-ROM M HEAD 36MM +0
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 4459769
• MDR Text Key: 5189259
• Report Number: 1818910-2015-12082
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK120599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Distributor,distributor,health p
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/31/2014

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: 10/02/2006
• Device Catalogue Number: 136531000
• Device Lot Number: XTD78
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2015
• Initial Date FDA Received: 01/28/2015
• Supplement Dates Manufacturer Received: Not provided; 01/25/2019; 04/29/2019
• Supplement Dates FDA Received: 03/20/2015; 01/29/2019; 04/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2001
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 83