MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE; PROSTHESIS, HIP

Catalog Number 00801803202

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part # 00625006525 / bone screw/ lot # 62466422.Part # 00625006525 / bone screw/ lot # 62466422.Part #00784802300 modular neck/ lot # 62335280.Part # 00771301000/ stem/ lot # 60743574.Part # 62025020 / shell / lot # 62064875.Part # 63105032 / liner/ lot # 62449618.Part # unknown / femoral head allograft/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2020-00277, 0001822565-2020-01866, 0001822565-2020-01865, 0001822565-2020-01884.

Event Description

It was reported that during a diagnostic radiology 4 years post implantation that there was bending of the screws of the left superior acetabulum.Slight leg length discrepancy, with the left leg longer than the right (1cm).No revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

Upon receipt of additional information, it was determined this device did not contribute to the reported event and should be voided.

Manufacturer Narrative

Upon receipt of additional information, it was determined this device did not contribute to the reported event and should be voided.

• Brand Name: FEMORAL HEAD STERILE
• 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 Key: 10091930
• MDR Text Key: 192172598
• Report Number: 0002648920-2020-00276
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 00801803202
• Device Lot Number: 62498217
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 07/10/2020
• Supplement Dates FDA Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 118