MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 36IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1221-36-056

Device Problems Disassembly (1168); Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Pain (1994); Joint Dislocation (2374); No Known Impact Or Consequence To Patient (2692); Not Applicable (3189); No Code Available (3191); Swelling/ Edema (4577)

Event Date 04/25/2018

Event Type  Injury  

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

Der states that the poly disassociated from cup.  doi: (b)(6) 2016; dor: (b)(6) 2018; right hip.

Manufacturer Narrative

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

Event Description

Litigation records received alleging that one year and four months after the primary surgery, the patient's right hip popped after bending.Diagnostic testing (according to the litigation record) has indicated that the humeral head was riding high in the acetabular compartment and that there was a dislocation.The patient was forced to undergo a head and liner exchange.The records further allege severe and permanent injury, pain, suffering, disability and the need for a revision surgery.Doi: (b)(6) 2016 - dor: (b)(6) 2018; (right hip).

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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After review of the medical records the patient was revised to address failed right tha with liner dissociation.Pop sensation of the hip, grinding and squeaking-type sensation and pain after bending over.However, xray reported no evidence of hip dislocation.Ct scan confirmed evidence of liner dissociation.Operative note reported capsule under tension with fluid, this was black tarnished from the ceramic on metal contact.There was thick blackened synovium in the joint that were debrided.There was difficulty implanted the head due to native retroversio.

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: e3 initial reporter occupation: lawyer.Added: a4, b5, b7, d10 and h6 (patient).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a2 (age), e1, e2, e3 (removed), g1, g2 and h6 (patient, device).Replaced surgical intervention with device revision or replacement.

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.

• Brand Name: ALTRX NEUT 36IDX56OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7538184
• MDR Text Key: 109052862
• Report Number: 1818910-2018-60371
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016342
• UDI-Public: 10603295016342
• Combination Product (y/n): N
• PMA/PMN Number: K062148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/25/2018

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 Expiration Date: 09/30/2021
• Device Model Number: 1221-36-056
• Device Catalogue Number: 122136056
• Device Lot Number: H00457
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 06/20/2018; 11/18/2019; 02/17/2020; 06/17/2021; 08/05/2021
• Supplement Dates FDA Received: 06/27/2018; 12/12/2019; 02/20/2020; 07/05/2021; 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 36MM +12; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR W/GRIPTION 56MM; TRI-LOCK BPS SZ 3 STD OFFSET
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 93