MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 32IDX62OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-32-062
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Surgeon reported to nca (bfarm): "hip-tep left side on (b)(6) 2013 in our hospital.Since (b)(6)2020, after a rotational movement while working in the garden, patient was experiencing increasing pain and discomfort in the left hip joint.After this, he experienced squeaking noises in the left joint plus functional restrictments and pain under load.Hip-tep right side in 3/2007; content with this one.The x-ray examination indicated a dislocated inlay of the hip-tep on the left.Revision of left hip-tep on (b)(6) 2020.".
Event or Problem Description
On (b)(6) 2020 the patient was revised for left hip tilted, dislocated cup insert (disassociation).The liner and cup was revised.Cup insert appears tilted and rotated, now opening in a lateral direction, resulting in impingement of the head at the lateral acetabular margin.
Additional 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.H6 health effect clinical code - appropriate term/code not available (e2402) is used to capture joint injury.
Additional 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.
Additional 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: d10 concomitant med products.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned device along with the attached x-ray images confirmed a disassociation event.Error in materials or manufacture 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 : dhr has been reviewed and no deviations or anomalies were found.

• Brand Name: PINN MAR NEUT 32IDX62OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10808928
• Report Number: 1818910-2020-24169
• Device Sequence Number: 4089853
• Product Code: LPH
• UDI-Device Identifier: 10603295013952
• UDI-Public: 10603295013952
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K983014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/22/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1219-32-062
• Device Catalogue Number: 121932062
• Device Lot Number: 307238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 11/23/2020; 12/01/2020; 12/14/2020; 01/14/2021; 01/19/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 11/30/2020; 12/16/2020; 12/21/2020; 01/18/2021; 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; CORAIL2 STD SIZE 13; DELTA CER HEAD 12/14 32MM +9; PINNACLE 100 ACET CUP 62MM; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR