MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. - 1818910 ALTRX +4 NEUT 40IDX56OD; HIP ACETABULAR INSERT/LINER

Catalog Number 122140456

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Scarring (2061); Injury (2348); Joint Disorder (2373); Ambulation Difficulties (2544); Not Applicable (3189); No Code Available (3191)

Event Date 10/31/2012

Event Type  Injury  

Event Description

Patient was revised to address subluxation.Update 6/4/15-pfs and medical records received.Pfs alleges subluxation.A correct doi was provided.After review of the medical records for mdr reportability, the revision operative note indicated the patient was revised for subluxation.Only the femoral head was revised.The complaint was updated on:7/2/2015.

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).

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.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible for the unknown lot code(s).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

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Update ad 16 apr 2018: (b)(4) was re-opened under (b)(4) due to the receipt of ppf pfs and medical records.In addition to what were previously alleged, pfs alleges injury, pain, inability to ambulate, and feeling that the hip would dislocate.It was also stated that the patient still has difficulty walking and inability to perform daily activities.After the review of medical records for mdr reportability, it was stated that the patient had a third revision to address subluxing femoral head and internal snapping hip secondary to iliopsas tenting.Revision notes reported extensive scar tissue, loss of offset and leg length due to short neck length as well as thin capsule anteriorly, patient had a mild leg length discrepancy.Doi: (b)(6) 2011(liner); doi: (b)(6) 2011(head) dor: (b)(6) 2012; left hip.

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.H10 additional narrative:  added: g3 and h6 (device).

• Brand Name: ALTRX +4 NEUT 40IDX56OD
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. - 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 4888497
• MDR Text Key: 6067353
• Report Number: 1818910-2015-24976
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK062148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,consumer,distributor,he
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/04/2015

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: 07/27/2011
• Device Catalogue Number: 122140456
• Device Lot Number: 128716
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2015
• Initial Date FDA Received: 07/02/2015
• Supplement Dates Manufacturer Received: Not provided; 04/16/2018; 07/08/2020
• Supplement Dates FDA Received: 08/03/2015; 05/15/2018; 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 66