MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Test Result (2695); No Code Available (3191)

Event Date 02/05/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.The complaint was received into the company in the form of a literature paper with the following comment: literature article entitled, ¿retrospective cohort study of the performance of the pinnacle metal on metal (mom) total hip replacement: a single-centre investigation in combination with the findings of a national retrieval centre¿ by david john langton, et al, published by bmj open (2016), vol.6, article number e007847, doi:10.1136/bmjopen-2015-007847.No products were received and no further product information was received.The literature paper was forwarded to clinical specialists for review.They commented: this article is a retrospective cohort study in combination with a prospective national retrieval study (northern retrieval registry (nrr)) the purpose of which is to determine risk factors for revision in patients implanted with a pinnacle metal on metal (mom) hip replacement.All patients implanted with a depuy pinnacle mom hip prosthesis were invited to attend for a review which included clinical examination, blood metal ion measurements, radiographs and targeted imaging.Explanted components underwent wear analysis using validated methodology and these results were compared with those obtained from the nrr.489 mom pinnacle hips were implanted into 434 patients (243 females and 191 males).Of these, 352 patients attended the mom recall clinics.64 patients had died during the study period.For the purposes of survival analysis, non-attendees were assumed to have well-functioning prostheses.The femoral components were manufactured by depuy.The s-rom stem was combined with ultamet head and the corail stem was paired with the articul/eze stem.These head/stem combinations were used with all patients analyzed in this study.The mean follow-up of the cohort was 89 months.71 hips were revised.All but one of the revisions were carried out for armd, with one revision for a loose cup.In only one case was no abnormal fluid identified at revision.In 53 cases (75%), copious amounts of fluid were found, and in 32 (45%), it was noted to be under pressure or had fistulated through the capsule.Obvious damage to the abductor musculature was noted in 38 cases.Moderate-to-severe aseptic lymphocyte dominated vasculitis associated lesion (alval) was documented on examination of retrieved tissues in 36 cases (51%).In 13 cases (19%), histological findings were solely those of metallosis with no lymphocytic infiltration identified.Fifty of the 71 (70%) failures involved taper failure.Thirty-four failures (48%) involved bearing failure.The corail stem was not significantly associated with a greater risk of taper failure than the srom stem.The median blood ions levels in patients implanted with failed bilateral thas was 9.72 ppb (cr) and 9.54 ppb (co).The blood ion levels did not reach the 7 ppb threshold in patients implanted with unilateral thas.The pseudotumors, metal debris, and increased joint fluid were confirmed both intraoperatively and histologically.Corrosion of the taper was found on both the corail and s-rom explanted stems.The authors allege that there were variations in the manufactured clearance rates of random batches of the pinnacle cups and liners, particularly those manufactured after 2006.Figure 2 includes a picture of a ¿gap¿ between the head and liner which was calculated by subtracting the diameter of the head from the diameter of the liner.The authors did not return these explanted products to depuy for investigation and analysis to substantiate this allegation.Pertaining to this issue, the authors note, ¿without a large number of sterile implants from the different years of manufacture, however, it is currently impossible to know whether variation in taper surface finishes in and of itself explains the difference in failure rates between the patient cohorts pre-2006 and post-2006.¿ the authors do not identify specific adverse events with individual patients or particular head/stem variations within the text of this article.Without returned parts, no further investigation of the associated products can be made.No investigation as to manufacturing defects can be made without product codes and batch numbers.Post-market surveillance is per sep-(b)(4).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.(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

Literature article entitled, ¿retrospective cohort study of the performance of the pinnacle metal on metal (mom) total hip replacement: a single-centre investigation in combination with the findings of a national retrieval centre¿ by david john langton, et al, published by bmj open (2016), vol.6, article number e007847, doi:10.1136/bmjopen-2015-007847, was reviewed for mdr reportability.This article is a retrospective cohort study in combination with a prospective national retrieval study (northern retrieval registry (nrr)) the purpose of which is to determine risk factors for revision in patients implanted with a pinnacle metal on metal (mom) hip replacement.All patients implanted with a depuy pinnacle mom hip prosthesis were invited to attend for a review which included clinical examination, blood metal ion measurements, radiographs and targeted imaging.Explanted components underwent wear analysis using validated methodology and these results were compared with those obtained from the nrr.489 mom pinnacle hips were implanted into 434 patients (243 females and 191 males).Of these, 352 patients attended the mom recall clinics.64 patients had died during the study period.For the purposes of survival analysis, non-attendees were assumed to have well-functioning prostheses.The femoral components were manufactured by depuy.The s-rom stem was combined with ultamet head and the corail stem was paired with the articul/eze stem.These head/stem combinations were used with all patients analyzed in this study.The mean follow-up of the cohort was 89 months.71 hips were revised.All but one of the revisions were carried out for armd, with one revision for a loose cup.In only one case was no abnormal fluid identified at revision.In 53 cases (75%), copious amounts of fluid were found, and in 32 (45%), it was noted to be under pressure or had fistulated through the capsule.Obvious damage to the abductor musculature was noted in 38 cases.Moderate-to-severe aseptic lymphocyte dominated vasculitis associated lesion (alval) was documented on examination of retrieved tissues in 36 cases (51%).In 13 cases (19%), histological findings were solely those of metallosis with no lymphocytic infiltration identified.Fifty of the 71 (70%) failures involved taper failure.Thirty-four failures (48%) involved bearing failure.The corail stem was not significantly associated with a greater risk of taper failure than the srom stem.The median blood ions levels in patients implanted with failed bilateral thas was 9.72 ppb (cr) and 9.54 ppb (co).The blood ion levels did not reach the 7 ppb threshold in patients implanted with unilateral thas.The pseudotumors, metal debris, and increased joint fluid were confirmed both intraoperatively and histologically.Corrosion of the taper was found on both the corail and s-rom explanted stems.The authors allege that there were variations in the manufactured clearance rates of random batches of the pinnacle cups and liners, particularly those manufactured after 2006.Figure 2 includes a picture of a ¿gap¿ between the head and liner which was calculated by subtracting the diameter of the head from the diameter of the liner.The authors did not return these explanted products to depuy for investigation and analysis to substantiate this allegation.Pertaining to this issue, the authors note, ¿without a large number of sterile implants from the different years of manufacture, however, it is currently impossible to know whether variation in taper surface finishes in and of itself explains the difference in failure rates between the patient cohorts pre-2006 and post-2006.¿ the authors do not identify specific adverse events with individual patients or particular head/stem variations within the text of this article.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9143494
• MDR Text Key: 166708076
• Report Number: 1818910-2019-106885
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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