MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN MAR ETO NEUT 32IDX48OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number 122432048

Device Problem Separation Problem (4043)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 03/12/2019

Event Type  Injury  

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

It was reported that the patient fell down around in (b)(6) 2018 and felt pain and something wrong with hip joint, thus, the revision surgery was performed on (b)(6) 2019 by replacing the liner, the head due to dislocation of the liner.It was confirmed the screw head was protruded, so there was also a possibility of the cause was fixation failure by it.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> no device was returned.Root cause undetermined depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Investigation methods: was patient affected: yes.Device history reviewed: yes.Lot trace obtained: no.Complaints database searched: yes.Product checked: no.Label checked: no.Product pulled from stock for inspection: no a review of complaint databases did not identify any anomalies.A manufacturing record evaluation was performed for the finished device lot 674463 and no non-conformances were identified the x-rays were reviewed by bioengineering and a report was received stating; it can be seen that the right femoral head is not centralised in the cup.This could possibly be due to liner disassociation or liner wear.The image (b)(4) provided suggests that the liner may have disassociated from the shell.Reviewing the photo provided ((b)(4)): the wear visible on the rim of the liner may suggest impingement with the femoral stem or retrieval damage, however it is difficult to confirm either as the parts have not been returned for visual inspection.From this photo, it is not possible to investigate the femoral head.Conclusion: as stated in the event description, the screws were reported to be protruded.This would impact the seating of the liner, however it is not possible to investigate this from the information provided.It should be noted that the mode of failure of the prosthesis is multi-factorial and consideration has to be given to all other potential influences such as, surgical process, patient variables e.G.Activity, weight, bmi and use, anatomical considerations and patient changes over time.This report details the findings from a review of the given x-rays and information as supplied at the time of evaluation.Any conclusions from this data have to be placed into context with all other relevant factors.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event no information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per (b)(4).Device history lot
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> a manufacturing record evaluation was performed for the finished device lot 674463 and no non-conformances were identified 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

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 was returned.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Investigation methods: was patient affected: yes.Device history reviewed: yes.Lot trace obtained: no.Complaints database searched: yes.Product checked: no.Label checked: no.Product pulled from stock for inspection: no.A review of complaint databases did not identify any anomalies.A manufacturing record evaluation was performed for the finished device lot 674463 and no non-conformances were identified.The x-rays were reviewed by bioengineering and a report was received stating; it can be seen that the right femoral head is not centralised in the cup.This could possibly be due to liner disassociation or liner wear.The image (jo20190112_photo.Pdf) provided suggests that the liner may have disassociated from the shell.Reviewing the photo provided (jo20190112_photo.Pdf): the wear visible on the rim of the liner may suggest impingement with the femoral stem or retrieval damage, however it is difficult to confirm either as the parts have not been returned for visual inspection.From this photo, it is not possible to investigate the femoral head.Conclusion: as stated in the event description, the screws were reported to be protruded.This would impact the seating of the liner, however it is not possible to investigate this from the information provided.It should be noted that the mode of failure of the prosthesis is multi-factorial and consideration has to be given to all other potential influences such as, surgical process, patient variables e.G.Activity, weight, bmi and use, anatomical considerations and patient changes over time.This report details the findings from a review of the given x-rays and information as supplied at the time of evaluation.Any conclusions from this data have to be placed into context with all other relevant factors.- without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.- the device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep 419.Device history lot
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> a manufacturing record evaluation was performed for the finished device lot 674463 and no non-conformances were identified.Device history batch
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> null.Device history review
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> 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.

• Brand Name: PINN MAR ETO NEUT 32IDX48OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw; warsaw IN 46582 0988
• MDR Report Key: 8473163
• MDR Text Key: 140612460
• Report Number: 1818910-2019-89292
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 122432048
• Device Lot Number: 674463
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 53