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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. COCR FEMORAL HEAD; PROSTHESIS, HIP
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ZIMMER MANUFACTURING B.V. COCR FEMORAL HEAD; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Corroded (1131); Material Erosion (1214); Unstable (1667); Device Dislodged or Dislocated (2923); Insufficient Information (3190)
Patient Problems Host-Tissue Reaction (1297); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Swelling (2091); Tissue Damage (2104); Joint Dislocation (2374); No Information (3190)
Event Date 06/26/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple reports were filed for this event: 0001822565-2019-04876.
 
Event Description
It was reported a patient underwent right total hip arthroplasty.Subsequently, the patient underwent a revision procedure approximately 5 years after the initial surgery due to unknown reasons.Attempts were made to obtain additional information; however, none was available.
 
Event Description
It was reported a patient had an initial right tha.Subsequently the patient was revised approximately 5 years post implantation due to infection, recurrent instability and dislocation, elevated metal ion levels, tissue damage, pseudotumor/pseudocapsule, pain, swelling, bone remodeling, necrosis, and in-vivo corrosion.It was decided to do a two-stage revision with antibiotic cement spacer.Attempts were made to obtain additional information; however, none was available.Medical records indicated: superficial soft tissues noted to be fairly edematous; when the fascia was opened, a large amount of clear yellow fluid was expressed; brown material visualized consistent with pseudotumor formation; no joint capsule visualized; erosion into the greater trochanter; abductor muscles were completely gone; greater trochanter was bald with brown appearing tissue that appeared necrotic; excess bone formation around the proximal femur.
 
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g4, g7, h2, h3, h6, h10.The following section was corrected: d4 - device expiration date.The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.The device history records were reviewed and no discrepancies were identified.Review of the sterility certificates confirmed that the products were sterilized per specifications.A definitive root cause could not be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
COCR FEMORAL HEAD
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
MDR Report Key9339439
MDR Text Key166900073
Report Number0002648920-2019-00841
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
PMA/PMN Number
K063251
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,health p
Type of Report Initial,Followup,Followup
Report Date 04/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2022
Device Model NumberN/A
Device Catalogue Number00801803602
Device Lot Number62161492
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/24/2019
Initial Date FDA Received11/18/2019
Supplement Dates Manufacturer Received11/13/2019
03/31/2020
Supplement Dates FDA Received12/10/2019
04/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
BONE SCREW, PN 00625006530, LN 62273309.; CONTINUUM SHELL, PN 00875705201, LN 62220475.; CONTINUUM, PN 00885101036, LN 62208586.; KINECTI NECK, PN 00784801200, LN 62191309.; MODULAR FEMORAL STEM, PN 00771300700, LN 62198172.; BONE SCREW, PN 00625006530, LN 62273309; CONTINUUM SHELL, PN 00875705201, LN 62220475; CONTINUUM, PN 00885101036, LN 62208586; KINECTI NECK, PN 00784801200, LN 62191309; MODULAR FEMORAL STEM, PN 00771300700, LN 62198172
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age63 YR
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