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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX50OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX50OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Catalog Number 121887350
Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Joint Dislocation (2374); Ambulation Difficulties (2544); Joint Laxity (4526); Physical Asymmetry (4573); Swelling/ Edema (4577)
Event Date 02/15/2021
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.
 
Event Description
Revision pinnacle metal liner because of methalosis.No surgical delay.No reported product deficiency.Doi (b)(6) 2009, dor (b)(6) 2021.
 
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.
 
Event Description
A.Was surgery time extended? if yes, what is the duration of the delay? answer: no.B.What is the affected side involved in this event? answer: methallosis.C.Are the products available for return? answer: shipped to cg labs.G.Was there any suggestion by anyone indicating that there was or may be deficiency with the product(s)? answer: no.H.Can you confirm the name of the hospital where the revision surgery was done? answer: (b)(6).I.Can you please confirm if the head is also a depuy product? if yes, please provide product and lot details.Answer: yes-code:136536310 lot:3190861.
 
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.
 
Event Description
As per additional information received, it was indicated that the doi (b)(6) 2009 however we have identified that the product/lot combinations provided for the liner and was not yet available until (b)(6) 2010.Could you please re-verify product details for hte liner or the date of implant or was there a previous revision that involves depuy products? if yes, please provide product details or if it was previously reported kindly provide a complaint number.Answer: in the attachment (notes & attachments) you have an example of deregistration from that operation on which the date of the operation is visible (b)(6) 2009 and all the components that were installed during that operation.Please confirm if head was revised? answer: the head has been revised as well.Can you please clarify what you mean by "squizing and after that luksation"? was squeaking and luxation? answer: the luxation occurred primarily and that is the reason for the audit.After that, when they opened the patient, they saw that it was also metallosis.Squeezing was also but that was not the reason for the operation.Squeezing occurs with this combination of implants.
 
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.
 
Event Description
The revision surgery occurred on (b)(6) 2021 on the left hip.Prior to revision, patient was having pain and instability in the left hip.Primary implantation was in 2010 and since then had occasional feelings of "skipping" in the hip.Patient was dislocated in 2017 and 2020 requiring a "readjustment" in the hospital both times.The patient has had limping, walking difficulty and fear of falling.The patient's left leg was 5mm longer than the right.Surgeon also stated that the patient had a r tha in 2009 requiring revision in 2015 due to metallosis, though no indication of manufacturer.The revision surgery was performed where heavy, dark effusion and a large mass of brittle granulation tissue was found.Osteolysis was noted around the proximal part of the stem and around the cup.The cup and stem were left in situ.
 
Manufacturer Narrative
Product complaint # : pc-(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.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device and x-ray images did not identify any product defects or anomalies.Depuy considers the investigation closed.Should additional info be received, 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.Corrected: h3.
 
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Brand Name
PINNACLE MTL INS NEUT36IDX50OD
Type of Device
PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11399817
MDR Text Key234283004
Report Number1818910-2021-04173
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K062426
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number121887350
Device Lot Number3122538
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2021
Date Manufacturer Received05/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
CANCELLOUS BONE SCREW 6.5X25MM; DELTA CER HEAD 12/14 36MM +1.5; PINNACLE MTL INS NEUT36IDX50OD; PINNACLE SECTOR II CUP 50MM; UNKNOWN HIP FEMORAL STEM
Patient Outcome(s) Required Intervention;
Patient Age78 YR
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