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 Unspecified Infection (1930); Pain (1994); Test Result (2695); No Code Available (3191)

Event Date 01/14/2009

Event Type  Injury  

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.(b)(4).

Event Description

Literature article entitled, ¿ceramic-on-metal bearings in total hip replacement: whole blood metal ion levels and analysis of retrieved components¿ by g.H.Isaac, et al, published by the journal of bone and joint surgery (2009), vol.91-b, pp.1134-1141, doi: 10.1302/0301-620x.91b9, was reviewed for mdr reportability.This report consists of two parts.First, a further clinical review of whole blood metal ion data from the com and mom bearings reported previously,13 but with an increase in the number of patients and a longer duration of follow-up.Second, a laboratory examination of two explanted com bearings to assess any in vivo changes, and to assess their effect on the wear performance of the com bearings by comparing the wear of the explanted bearings with three new com implants in a hip joint wear simulator.All the patients received identical components, a corail ha-coated femoral component and a pinnacle acetabular component, both made from ti-6a1-4v alloy.In the data reported here the bearing surfaces comprised a 28 mm diameter femoral head made from either zirconia toughened alumina (biolox delta) or wrought high-carbon, cobalt-chrome-molybdenum alloy (ultamet) articulating against a wrought high-carbon, cobalt-chrome-molybdenum alloy (ultamet) acetabular liner.All components were supplied by depuy.Two retrieved components were available for analysis.Both were revised for reasons unrelated to the bearing surface (sample a: infection, sample b: periprosthetic fracture).Visual inspection of the explanted bearings showed some evidence of transfer material on the ceramic heads.Examination of the metal acetabular component (only sample a was available) showed no evidence of rim damage and only slight evidence of scratching within the bearing surface.There were eight ¿outliers¿ (either cr or co > 10 g/l), four in each of the com and mom groups.These were generally related to component position.With the exception of two marginal outliers (< 15 g/l), one in each group, the other six outliers had either a high acetabular component abduction angle (> 50°) or a high anteversion angle (> 25°), or in some cases both.These six outliers were therefore outside the lewinnek safe zone of 30° to 50° of inclination and 5° to 25° of anteversion.At the latest follow-up for each of the outliers, the mean com, cr and co levels were 11.29 g/l and 28.06 g/l, respectively and the comparable levels for mom were 32.61 g/l and 48.83 g/l.Of the two retrieved components, sample b was only implanted five weeks prior to revision, had only the head available for analysis, and no meaningful metal ion data.Sample a was revised for infection, but the patient had suffered a fall.It is likely that this bearing was articulating normally prior to retrieval, suggesting that significant metal transfer on to the ceramic head is a normal and non-detrimental feature of com wear in vivo.The authors do not specify patient and component data with the elevated blood metal ions noted within this study.The new samples tested in this study were provided by depuy international, leeds.This work was supported by depuy international ltd.There were no adverse events related to the implanted corail stems.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (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, ¿ceramic-on-metal bearings in total hip replacement: whole blood metal ion levels and analysis of retrieved components¿ by g.H.Isaac, et al, published by the journal of bone and joint surgery (2009), vol.91-b, pp.1134-1141, doi:10.1302/0301-620x.91b9 no products were received and no further product information was received.The literature paper was forwarded to clinical specialists for review.They commented: this report consists of two parts.First, a further clinical review of whole blood metal ion data from the com and mom bearings reported previously,13 but with an increase in the number of patients and a longer duration of follow-up.Second, a laboratory examination of two explanted com bearings to assess any in vivo changes, and to assess their effect on the wear performance of the com bearings by comparing the wear of the explanted bearings with three new com implants in a hip joint wear simulator.All the patients received identical components, a corail ha-coated femoral component and a pinnacle acetabular component, both made from ti-6a1-4v alloy.In the data reported here the bearing surfaces comprised a 28 mm diameter femoral head made from either zirconia toughened alumina (biolox delta) or wrought high-carbon, cobalt-chrome-molybdenum alloy (ultamet) articulating against a wrought high-carbon, cobalt-chrome-molybdenum alloy (ultamet) acetabular liner.All components were supplied by depuy.Two retrieved components were available for analysis.Both were revised for reasons unrelated to the bearing surface (sample a: infection, sample b: periprosthetic fracture).Visual inspection of the explanted bearings showed some evidence of transfer material on the ceramic heads.Examination of the metal acetabular component (only sample a was available) showed no evidence of rim damage and only slight evidence of scratching within the bearing surface.There were eight ¿outliers¿ (either cr or co > 10 ¿g/l), four in each of the com and mom groups.These were generally related to component position.With the exception of two marginal outliers (< 15 ¿g/l), one in each group, the other six outliers had either a high acetabular component abduction angle (> 50°) or a high anteversion angle (> 25°), or in some cases both.These six outliers were therefore outside the lewinnek safe zone of 30° to 50° of inclination and 5° to 25° of anteversion.At the latest follow-up for each of the outliers, the mean com, cr and co levels were 11.29 ¿g/l and 28.06 ¿g/l, respectively and the comparable levels for mom were 32.61 ¿g/l and 48.83 ¿g/l.Of the two retrieved components, sample b was only implanted five weeks prior to revision, had only the head available for analysis, and no meaningful metal ion data.Sample a was revised for infection, but the patient had suffered a fall.It is likely that this bearing was articulating normally prior to retrieval, suggesting that significant metal transfer on to the ceramic head is a normal and non-detrimental feature of com wear in vivo.The authors do not specify patient and component data with the elevated blood metal ions noted within this study.The new samples tested in this study were provided by depuy international, leeds.This work was supported by depuy international ltd.There were no adverse events related to the implanted corail stems.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-419.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.Device history lot: null.Device history batch: null.Device history review: null.

• 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
• MDR Report Key: 9162837
• MDR Text Key: 167156065
• Report Number: 1818910-2019-106894
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• 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
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention