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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 36MM +3 HIWALL LNR SZ23 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. E-POLY 36MM +3 HIWALL LNR SZ23 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); Swelling (2091); Tissue Damage (2104); Hip Fracture (2349); Reaction (2414)
Event Date 02/13/2017
Event Type  Injury  
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) was reviewed and no discrepancies were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.
 
Manufacturer Narrative
(b)(4). This follow-up report is being filled to relay a additional information, which was unknown at the time of the initial medwatch. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient's left hip was revised 3 years post implantation due to gross metallosis throughout the soft tissues emanating from the hip to the level of the skin with multiple fractured polyethylene liner fragments as well as complete protrusion of the ceramic femoral head with 3 acetabular components with significant metal staining of the femoral head, asymmetric location of the femoral head with soft tissue swelling concerning for failure of the acetabular polyethylene liner with subsequent generation of metal debris. There was noted to be blackened staining around the proximal aspect of the femoral component. No polyethylene liner remaining. There was complete wear superiorly through the acetabular shell.
 
Manufacturer Narrative
Reported event was confirmed by review of revision operative notes. Device history record (dhr) was reviewed and no discrepancies were found. Review of the complaint history determined that no further action(s) is/are required. Root cause remains unable to be determined as the necessary information to adequately investigate the reported event was not 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
It was reported that the patient's left hip was revised 3 years post implantation due to gross metallosis throughout the soft tissues emanating from the hip to the level of the skin with multiple fractured polyethylene liner fragments as well as complete protrusion of the ceramic femoral head with 3 acetabular components with significant metal staining of the femoral head, asymmetric location of the femoral head with soft tissue swelling concerning for failure of the acetabular polyethylene liner with subsequent generation of metal debris. There was noted to be blackened staining around the proximal aspect of the femoral component. No polyethylene liner remaining. There was complete wear superiorly through the acetabular shell. Patient was revised to a competitor product.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Complaint sample was evaluated and the reported event was confirmed. Visual inspection oft he liner showed that it was fractured into six pieces. Black debris was identified on the surface of the liner as well as in the back of the liner. 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 additional event information to report at this time.
 
Manufacturer Narrative
This report is being submitted to relay additional information. Report source: legal notification. Reported event was confirmed due to medical records received. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Review of complaint history determined that no further action is required as no trends were identified. Root cause was unable to be determined. 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. Multiple reports have been submitted for this event. Please see associated reports: 0001825034-2017-07952, 0001825034-2017-07953, 0001825034-2017-07954, 0001825034-2018-02791.
 
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. Concomitant medical products: 11-106052, r/b rloc lhole shl 52mm sz 23, 394190; 650-1057, cer bioloxd option hd 36mm, 411390; 11-103203, taperloc por lat fmrl 9x137, 172200; 650-1064, cer option type 1 tpr sleve -6, 231850. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 07952, 0001825034 - 2017 - 07954. Product location unknown.
 
Event Description
It is reported by the patient's legal counsel that the patient underwent right total hip arthroplasty. Subsequently, the patient was revised due to allegations of metallosis, metal debris, and asymmetric location of the femoral head with soft tissue swelling. It is also reported that the patient's hip had shattered into multiple fragments, and the head was significantly out of place. Attempts have been made and additional information on the reported event is unavailable.
 
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Brand NameE-POLY 36MM +3 HIWALL LNR SZ23
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key6927891
MDR Text Key114740641
Report Number0001825034-2017-07953
Device Sequence Number1
Product Code MAY
Combination Product (y/n)N
PMA/PMN Number
PK090103
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Model NumberN/A
Device Catalogue NumberEP-108323
Device Lot Number821420
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/31/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 10/08/2017 Patient Sequence Number: 1
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