MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 PINNACLE 100 ACET CUP 56MM; HIP ACETABULAR CUP

Catalog Number 121701056

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 03/28/2017

Event Type  Injury  

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

Event Description

Disassociation of marathon inlay from pinnacle cup.Revision.

Manufacturer Narrative

Conclusion and justification status: the complaint states disassociation of marathon inlay from pinnacle cup.Revision.A complaint database search and review of manufacturing records did not identify any anomalies.The devices were reviewed by bioengineering alongside the x-rays and medical records.Implant disassociation was identified.Surgery report from revision thr on (b)(6) 2017 noted metal transfer on femoral head and liner migration to "lower acetabular circumference"; acetabular cup was noted to be undamaged; slight knocking of greater trochanter against the pelvis was noted due to pronounced soft tissue impingement, though no clear contact between stem neck and acetabular rim could be seen.The mode of failure of the prosthesis multi-factorial and consideration has to be given to all other potential influences such as, surgical process, patient variables i.E.Activity, weight, bmi and use, anatomical considerations and patient changes over time.This report details the finding of review of the explants 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 further information, the root cause of the complaint cannot be determined.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per sep 419 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The complaint states disassociation of marathon inlay from pinnacle cup.Revision.A complaint database search and review of manufacturing records did not identify any anomalies.The devices were reviewed by bioengineering alongside the x-rays and medical records.Implant disassociation was identified.Surgery report from revision thr on (b)(6)2017 noted metal transfer on femoral head and liner migration to "lower acetabular circumference"; acetabular cup was noted to be undamaged; slight knocking of greater trochanter against the pelvis was noted due to pronounced soft tissue impingement, though no clear contact between stem neck and acetabular rim could be seen.The mode of failure of the prosthesis multi-factorial and consideration has to be given to all other potential influences such as, surgical process, patient variables i.E.Activity, weight, bmi and use, anatomical considerations and patient changes over time.This report details the finding of review of the explants 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 further information the root cause of the complaint cannot be determined.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per (b)(6).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The complaint states disassociation of marathon inlay from pinnacle cup.Revision.A complaint database search and review of manufacturing records did not identify any anomalies.The devices were reviewed by bioengineering alongside the x-rays and medical records.Implant disassociation was identified.Surgery report from revision through on (b)(6) 2017 noted metal transfer on femoral head and liner migration to "lower acetabular circumference"; acetabular cup was noted to be undamaged; slight knocking of greater trochanter against the pelvis was noted due to pronounced soft tissue impingement, though no clear contact between stem neck and acetabular rim could be seen.The mode of failure of the prosthesis multi-factorial and consideration has to be given to all other potential influences such as, surgical process, patient variables i.E.Activity, weight, bmi and use, anatomical considerations and patient changes over time.This report details the finding of review of the explants 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 further information the root cause of the complaint cannot be determined.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per sep 419 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE 100 ACET CUP 56MM
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6559646
• MDR Text Key: 74895590
• Report Number: 1818910-2017-17896
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121701056
• Device Lot Number: 323158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2013
• 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
• Patient Outcome(s): Required Intervention