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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BIOSTOP G CEM RESTR 16MM; CEMENT / CEMENT ACCESSORY
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DEPUY ORTHOPAEDICS INC US BIOSTOP G CEM RESTR 16MM; CEMENT / CEMENT ACCESSORY Back to Search Results
Catalog Number 546316000
Device Problem Insufficient Information (3190)
Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Pain (1994); Burning Sensation (2146); No Code Available (3191)
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.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
New etq record created in order to update etq (legal system) complaint number (b)(4).Reason for original complaint: litigation papers allege the patient was revised due to implant failure.Update rec'd 4/21/15- amended litigation papers received.Original litigation indicated that the patient was implanted with asr; however, amended litigation alleges that the patient was implanted with pinnacle.The products have been updated and follow-ups created.In addition to what was previously reported, litigation alleges the patient suffers from damage to her hip joints and body.Litigation identified that this complaint is for the right hip.Update 10/9/15 medical records received.After review of the medical records the patient had a poly/metal construct, not metal/metal.All implants are now being reported, as they cannot be excluded as the cause of pain.No revision operative note has been provided.Litigation papers allege the patient had pain and a lump and that "the top of implant needs replaced".At the time of this review there was no mention of lumps or need for revision in the medical documents provided.The complaint was updated on:10/30/2015.
 
Manufacturer Narrative
Examination of the reported devices was not possible as they were not returned.A search of the complaints databases identified one other report against the femoral head and no other reports against the remaining product/product lot code combinations.The investigation can draw no conclusions with the information made available.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.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.
 
Manufacturer Narrative
Udi: (b)(4).
 
Event Description
Ppf alleges metal wear, metallosis and elevated metal ions.
 
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 associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.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).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 caused or contributed to the potential event described in this report.No code available use for absence of treatment.
 
Event Description
Pfs alleged burning.No revision notes reported.Updated patient harm.Doi: (b)(6) 2011 dor: none reported right hip.
 
Manufacturer Narrative
Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Added: b5 and h6 (patient).Corrected: h6 (patient).H6 patient code: no code available (3191) used to capture the absence of treatment and burning sensation.
 
Event Description
Pfs alleged burning.Updated code for soft tissue injury.
 
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Brand Name
BIOSTOP G CEM RESTR 16MM
Type of Device
CEMENT / CEMENT ACCESSORY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key5195138
MDR Text Key30107046
Report Number1818910-2015-34251
Device Sequence Number1
Product Code JDK
Combination Product (y/n)N
PMA/PMN Number
PK943727
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2011
Device Catalogue Number546316000
Device Lot Number08E1302
Was Device Available for Evaluation? No
Date Manufacturer Received04/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age70 YR
Patient Weight55
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