MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 NEUT 32IDX48OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1221-32-448

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Joint Disorder (2373); No Code Available (3191); Unspecified Musculoskeletal problem (4535)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that due to poly wear and breakage, the head and liner were removed and replaced.Doi: (b)(6) 2009; dor: (b)(6) 2019; right hip.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision depuy synthes 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: examination of the acetabular liner does find evidence to support the reported disassociation event.Product error was not identified.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).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.  h10 additional narrative: added: d10, h6 (device code).Corrected: h3.

Manufacturer Narrative

Product complaint # (b)(4).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.  h10 additional narrative: added: d4 (lot), d11, h4.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : examination of the acetabular liner does find evidence to support the reported disassociation event.Product error was not identified.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.

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.H10 additional narrative: added: b5, b7 and h6 (clinical and device codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (impact code).

Event Description

Medical records received: (b)(6) 2009 right hip replacement with depuy products.9/9/2019 revision operative notes indicate the patient received a right total hip revision due to failed liner.Upon entering the joint, metallosis was encountered and debrided.The femoral head was noted to have some blackening.The liner was worn and fractured.The cup and stem were inspected and stated to have integrity intact without deficiency.Head and liner revised.No noted complications.

• Brand Name: ALTRX +4 NEUT 32IDX48OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9135933
• MDR Text Key: 161945169
• Report Number: 1818910-2019-106830
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016274
• UDI-Public: 10603295016274
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/09/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1221-32-448
• Device Catalogue Number: 122132448
• Device Lot Number: DN7CY1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 10/10/2019; 11/08/2019; 02/05/2020; 04/01/2021; 09/20/2022
• Supplement Dates FDA Received: 10/24/2019; 11/08/2019; 02/28/2020; 04/02/2021; 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2009
• 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 32IDX48OD; APEX HOLE ELIM POSITIVE STOP; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 32MM +1; DELTA CER HEAD 12/14 32MM +1; DELTA CER HEAD 12/14 32MM +1; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX35MM; PINN CAN BONE SCREW 6.5MMX35MM; PINNACLE SECTOR II CUP 48MM; PINNACLE SECTOR II CUP 48MM; SUMMIT DUOFIX TAP SZ6 HI OFF; SUMMIT DUOFIX TAP SZ6 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 147 KG