MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 NEUT 36IDX54OD; HIP ACETABULAR INSERT/LINER

Catalog Number 122136454

Device Problems Disassembly (1168); Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Ambulation Difficulties (2544); No Information (3190); No Code Available (3191); Joint Laxity (4526); Unspecified Musculoskeletal problem (4535); Swelling/ Edema (4577)

Event Date 09/30/2016

Event Type  Injury  

Manufacturer Narrative

Complete product detail has not been received at this time.If further information is received a follow-up medwatch will be filed as appropriate.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient correspondence: squeaking noise and pain while walking - lead patient to get x-ray and scan.Surgeon says poly is worn causing the head and cup to rub making the noise.Medical record authorization forms were received.Those forms indicate that the patient was revised on (b)(6) 2016.The patient's medical records were received.Medical records were reviewed for mdr reportability.The poly liner is being reported for wear.

Manufacturer Narrative

Patient correspondence: squeaking noise and pain while walking - lead patient to get x-ray and scan.Surgeon says poly is worn causing the head and cup to rub making the noise.Update received 11/15/2016.Medical record authorization forms were received.Those forms indicate that the patient was revised on (b)(6) 2016.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided.Medical records were reviewed.The investigation can draw no conclusion regarding the reported event with the information available.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy considers the investigation closed.Should additional information be received the investigation will be reopened.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Update rec'd (b)(6) 2016: medical records received.After review of the medical records for mdr reportability, it appears the patient was revised on (b)(6) 2016.No revision operative note has been provided-just progress notes.Progress note from (b)(6) 2016 indicates dissociation and rim fracture of the liner.The cup is now being reported for the dissociation.

Manufacturer Narrative

Patient correspondence: squeaking noise and pain while walking - lead patient to get x-ray and scan.Surgeon says poly is worn causing the head and cup to rub making the noise.*update received 11/15/16.Medical record authorization forms were received.Those forms indicate that the patient was revised on (b)(6) 2016.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided.Medical records were reviewed.The investigation can draw no conclusion regarding the reported event with the information available.Based on the inability to determine root cause, the need for corrective action has not been 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

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).

Event Description

Update 03/10/2017 medical records received.After review of the medical records for mdr reportability, part/lot numbers were provided.The complaint was updated on: 03/27/2017.

Manufacturer Narrative

No device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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).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, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary (b)(6) 2021.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.Corrected: g1.

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.Device history lot - the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H10 additional narrative: added: d10 and h6.

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

Event Description

Medical records received.Doi: (b)(6) 2011: primary left hip implanted to treat osteoarthritis.Part lot provided on sticker sheet located on page 4.Dor: (b)(6) 2016: patient received a left hip revision to treat pain, instability, walking difficulty, squeaking secondary to liner fracture, and disassociation.Upon entering the joint effusion, scar tissue, and acetabular metallic debris/metallosis was excised.The liner was worn, fractured, and disassociated from the cup.There was minimal metal wear on the rim of the cup that was cleaned, and the cup was retained.There was some wear on the explanted head due to the metal-on-metal articulation of the head and rim of the cup.The stem was well-fixed and retained.The patient received a ceramic head and polyethylene liner.The procedure was completed without complications.This event is captured on (b)(4) and will be updated with this information.No part lot for the revision products was provided.Dor: (b)(6) 2023: patient received a left hip revision to treat pain and walking difficulty secondary to a broken and worn liner.Upon entering the joint, scar tissue, adhesions, and metallosis were evacuated.The revised liner was worn completely through and fractured.The revised head had wear secondary to articulating on the cup.The cup was well-fixed with no evidence of wear and retained.The femoral stem was well-fixed and retained.The patient received depuy revision products.The procedure was completed without complications.This event is captured on (b)(4) and an activity will be created to re-open and update the pc.Doi: (b)(6) 2011; dor: (b)(6) 2016 ((b)(4)); dor: (b)(6) 2023 ((b)(4)); left hip.

• Brand Name: ALTRX +4 NEUT 36IDX54OD
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopedics drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 6112769
• MDR Text Key: 60356312
• Report Number: 1818910-2016-31749
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072963
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/10/2017

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: 05/31/2016
• Device Catalogue Number: 122136454
• Device Lot Number: 108063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; 05/10/2019; 02/17/2021; 06/29/2023; 07/17/2023
• Supplement Dates FDA Received: 11/23/2016; 12/16/2016; 01/27/2017; 03/27/2017; 05/02/2017; 05/10/2019; 02/19/2021; 06/29/2023; 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2011
• 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
• Treatment: ALTRX +4 NEUT 36IDX54OD.; APEX HOLE ELIM POSITIVE STOP.; DELTA CER HEAD 12/14 36MM +1.5.; PINNACLE 300 ACET CUP 54MM.; SUMMIT POR TAPER SZ7 STD OFF.
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 93 KG